Force transducting implant system for the mitigation of atrioventricular pressure gradient loss and the restoration of healthy ventricular geometry

ABSTRACT

An implant system for restoring and improving physiological intracardiac flow in a human heart is provided including a force transducting, structurally stabilizing, and functionally assisting ventricular inflatable cardiac implant within a human heart for restoring and improving physiologic intracardiac flow, restoring the ventricular vortex, preventing atrioventricular pressure gradient loss, mitigating valvular regurgitation, and utilizing native energy and force, via force transduction, to restore geometric elliptical proportion and function to the atria, the ventricles and ventricular walls, and the valvular apparatus itself.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 USC § 120 of U.S. patentapplication Ser. No. 16/293,474, filed Mar. 5, 2019, which claims thebenefit under 35 USC § 119(e) of U.S. Provisional Patent Application No.62/638,833, filed on Mar. 5, 2018, each of which is hereby incorporatedby reference in its entirety.

BACKGROUND

The present disclosure generally relates to an integrated forcetransducting, structurally stabilizing, and functional ventricularassisting inflatable, semi-rigid, or rigid integrated implant systemcontained within a human heart for restoring and improving physiologicintracardiac flow, mitigating atrioventricular pressure gradient loss,and utilizing the native energy and force of the atrioventricularpressure gradient, via force transduction (meaning the capture,collection, and transfer of existing native energy & force), to restoregeometric elliptical shape, healthy proportion, and proper function tothe atria, the ventricles, the ventricular walls, and the valvularapparatus itself.

BRIEF SUMMARY

In various embodiments, an implant system for restoring and changingphysiological intracardiac flow, mitigating atrioventricular pressuregradient loss and valvular regurgitation, and utilizing the nativepressure gradient as a reconstructive therapeutic force in a human heartis provided. The implant system includes a dual-force pressuremitigating implant having a one-way valve or check valve mounted withina ring structure that allows atrial blood to pass through it into theventricle but prevents ventricular blood from returning into the atrium.The dual-force pressure mitigating implant further includes a pressuremitigating assembly having a mechanical dual force structural housinghaving a proximal annular expanding ring structure, a distal suspensionring, and gradient funneling skirt, the proximal annular expanding ringstructure supporting the valve skirt that seals to the distal suspensionring, the distal suspension ring supporting the one-way or check valve.The implant system further includes an anchoring system comprising oneor more therapeutic base plate assemblies attachable to the heart's apexor wall or structures. The implant system further includes a universaltether assembly, comprising a tether or tethers or shaft, connectedbetween the pressure mitigating assembly and the anchoring system,wherein the pressure mitigating assembly remaining tethered to the apexof the heart via the shaft and via the apical base plate. The implantsystem further includes a conduit providing a fluidic connection and acontrol unit with multiple sealed chambers to control the volume in thefluidic lumens and bladders and to house sensor components.

In various embodiments, an implant system includes a vortex flowdirecting member or balloon or any other distal assembly. The vortexflow directing implant or distal system assembly intercepts, mitigates,directs, re-directs, steers, and/or vectors hemodynamic flow in onecardiac phase while substantially simultaneously sealing the ventricleduring the next cardiac phase and retains the atrioventricular pressuregradient and captures, harnesses, and delivers, via the tether or shaftto the base plate, native cardiac energy and force and nativeatrioventricular pressure gradient energy and force that is thendelivered to the ventricular structures, septum, and/or the ventricularwalls restoring the native valvulo-ventricular interaction.

In various embodiments, an intracardiac passive ventricular assist,support, and repair implant system is provided. The implant systemincludes a distal assembly, a shaft, and an apical base plate. Thedistal assembly is tethered to the apex of the heart via the shaft andthe apical base plate. The implant system further includes a controlunit and a connective multi-lumen tubing extending between the controlunit and the implant. The implant system is configured to be a universalfoundation of an integrated system and these combined components createthe foundation for an integrated ventricular support and repair system.

In various embodiments, an anchoring plate configured to position,anchor, and connect an implant directly to the papillary muscles,precisely transfer targeted force and energy to the papillary muscles,and utilize the native pressure gradient as a reconstructive force in ahuman heart is provided. The anchoring plate includes a ball mount witha male universal ball connector, a connection member extending from thecentral ball mount, a first fixation wire extending from the connectionmember, and a second fixation wire extending from the connection member.The first fixation wire has a curved distal end and a first anchor at adistal-most end, and the second fixation wire has a curved distal endand a second anchor at a distal-most end. The curved distal end of thesecond fixation wire oriented in an opposite direction and overlappingthe curved distal end of the first fixation wire. The anchoring systemfurther includes a shaft receiver coupling the ball mount and a shaftconnecting an atrioventricular distal attachment to the anchoring plate.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects, features and advantages of the devices, systems, andmethods described herein will be apparent from the following descriptionof particular embodiments thereof, as illustrated in the accompanyingdrawings. The drawings are not necessarily to scale, emphasis insteadbeing placed upon illustrating the principles of the devices, systems,and methods described herein.

FIG. 1 illustrates vortex formation and vortical hemodynamic flowpatterns of a healthy human heart according to an embodiment of thepresent disclosure.

FIG. 2 illustrates the dysfunctional vortex formation and dysfunctionalhemodynamic flow patterns of a human heart with a dilated cardiomyopathypathology, according to an embodiment of the present disclosure.

FIG. 3 illustrates the structures of a human heart according to anembodiment of the present disclosure.

FIG. 4 illustrates the structures of the human mitral valve according toan embodiment of the present disclosure.

FIG. 5 illustrates the hemodynamic flow patterns of the human heartaccording to an embodiment of the present disclosure.

FIG. 6 is a front view of an integrated Vortex Flow Directing Implantsystem according to an embodiment of the present disclosure.

FIG. 7 is a top view down of an integrated Vortex Flow Directing Implantsystem according to an embodiment of the present disclosure.

FIG. 8 illustrates a member; a front view of an outer inflatableballoon; an enlarged member or balloon as a vortical blood flowvectoring/steering force and a mitigating force for atrioventricularpressure gradient loss (MR reduction) according to an embodiment of thepresent disclosure.

FIG. 9 illustrates a member a front cross-section view of an innerinflatable balloon; an enlarged inner member or balloon and itsstructure as a vortical blood flow vectoring/steering force and amitigating force for atrioventricular pressure gradient loss (MRreduction) according to an embodiment of the present disclosure.

FIG. 10 illustrates a member front view for perspective, and the topdown view of the member flexed in the anterior and the posterioraccording to an embodiment of the present disclosure.

FIG. 11 illustrates a member capturing and harnessing energy and forceenabling force transduction to occur; the member being engaged by theanterior and posterior leaflet In Situ or inside the heart according toan embodiment of the present disclosure.

FIG. 12 illustrates an axial adjusting balloon inflated in across-section view and an exterior view according to an embodiment ofthe present disclosure.

FIG. 13 illustrates an axial adjusting balloon of FIG. 12 deflated in across-section and an exterior view according to an embodiment of thepresent disclosure.

FIG. 14 illustrates a front view and a top view of an apical base platewith a ball joint according to an embodiment of the present disclosure.

FIG. 15 illustrates a cut-away cross-sectional interior view of ahydraulically adjusting base plate with axial adjusting piston accordingto an embodiment of the present disclosure.

FIG. 16 illustrates a cut-away of a multi lumen tubing in perspectiveview according to an embodiment of the present disclosure.

FIG. 17 illustrates a perspective view of a control unit with fiveindependent chambers according to an embodiment of the presentdisclosure.

FIG. 18 is a side view of a Vortex Flow Directing Implant with theattached inflatable belt on the member according to an embodiment of thepresent disclosure.

FIG. 19 is a perspective view of a Vortex Flow Directing Implantaccording to an embodiment of the present disclosure.

FIG. 20 is a top down view of a Vortex Flow Directing Implant accordingto an embodiment of the present disclosure.

FIG. 21 illustrate side view, perspective view, and a top down views ofa member according to an embodiment of the present disclosure.

FIG. 22 is an enlarged cross sectional front view and cross sectionalperspective view of a Vortex Flow Directing Implant according to anembodiment of the present disclosure.

FIG. 23 is a front view of a Vortex Flow Directing Implant according toan embodiment of the present disclosure.

FIG. 24 is a side view of a Vortex Flow Directing Implant according toan embodiment of the present disclosure.

FIG. 25 is a top down view of a Vortex Flow Directing Implant accordingto an embodiment of the present disclosure.

FIG. 26 illustrates front, side, and perspective exterior views of asemi-lunar rigid inflatable member according to an embodiment of thepresent disclosure.

FIG. 27 illustrates front, side, and perspective cross sectional viewsof a semi-lunar rigid inflatable member with the inflatable posteriorside removed according to an embodiment of the present disclosure.

FIG. 28 is a top down cross sectional view of a semi-lunar rigidinflatable member with the inflatable posterior side removed accordingto an embodiment of the present disclosure.

FIG. 29 is a top down cross sectional view of a semi-lunar rigidinflatable member with the inflatable posterior side according to anembodiment of the present disclosure.

FIG. 30 is a front view of a Dual Force Pressure Mitigating Implantsystem according to an embodiment of the present disclosure.

FIG. 31 is a perspective view of a Dual Force Pressure MitigatingImplant according to an embodiment of the present disclosure.

FIG. 32A is a front view of a Dual Force Pressure Mitigating Implantsystem without a coapting-vectoring member according to an embodiment ofthe present disclosure.

FIG. 32B is a front view of a Dual Force Pressure Mitigating Implantsystem with a coapting-vectoring member according to an embodiment ofthe present disclosure.

FIG. 33 is a front view of a Dual Force Pressure Mitigating Implantsystem in situ or as positioned in the human heart according to anembodiment of the present disclosure.

FIG. 34 is a disassembled component side view of a pressure mitigatingassembly according to an embodiment of the present disclosure.

FIG. 35 is a disassembled component cross-section of a pressuremitigating assembly according to an embodiment of the presentdisclosure.

FIG. 36 is a flow illustration depicting a flow direction in systoleaccording to an embodiment of the present disclosure.

FIG. 37 is a flow illustration depicting a flow direction in diastoleaccording to an embodiment of the present disclosure.

FIG. 38 is a perspective view of a one-way valve or check valve in anopen position according to an embodiment of the present disclosure.

FIG. 39 is a perspective view of a one-way valve or check valve in thesemi-open position according to an embodiment of the present disclosure.

FIG. 40 is a perspective view of a one-way valve or check valve in theclosed position according to an embodiment of the present disclosure.

FIG. 41 is a perspective view of a Dual Force Pressure MitigatingImplant with a pressure mitigating assembly one-way valve or check valvein the closed position according to an embodiment of the presentdisclosure.

FIG. 42 is a perspective view of a Dual Force Pressure MitigatingImplant with the pressure mitigating assembly one-way valve or checkvalve in the semi-open position according to an embodiment of thepresent disclosure.

FIG. 43 is a perspective view of a Dual Force Pressure MitigatingImplant with the pressure mitigating assembly one-way valve or checkvalve in the open position according to an embodiment of the presentdisclosure.

FIG. 44 is a front view of a Dual Force Annular Implant with the dualforce implant as a separate distal shaft component of an integratedsystem according to an embodiment of the present disclosure.

FIG. 45 is a front view of a Dual Force Pressure Coapting Implantaccording to an embodiment of the present disclosure.

FIG. 46 is a perspective view of a Dual Force Pressure Coapting Implantaccording to an embodiment of the present disclosure.

FIGS. 47-49 illustrate side views of a Dual Force Pressure CoaptingImplant according to an embodiment of the present disclosure.

FIG. 47 is a side view of a Dual Force Pressure Coapting Implant with aone-way valve in the open position according to an embodiment of thepresent disclosure.

FIG. 48 is a side view of a Dual Force Pressure Coapting Implant with aone-way valve in the partial open position according to an embodiment ofthe present disclosure.

FIG. 49 is a side view of a Dual Force Pressure Coapting Implant with aone-way valve in the closed position according to an embodiment of thepresent disclosure.

FIG. 50 is a perspective view of a one-way valve in the closed positionaccording to an embodiment of the present disclosure.

FIG. 51 is a top view of a one-way valve in the closed positionaccording to an embodiment of the present disclosure.

FIG. 52 is a perspective view of a one-way valve in the open positionaccording to an embodiment of the present disclosure.

FIG. 53 is a top view of a one-way valve in the open position accordingto an embodiment of the present disclosure.

FIG. 54 is a perspective view of a Therapeutic Fixation Assemblyaccording to an embodiment of the present disclosure.

FIG. 55 is a top view of a Therapeutic Fixation Assembly according to anembodiment of the present disclosure.

FIG. 56 illustrates a portion of the human body and exemplary locationsfor performing a minimally invasive surgical procedure according to anembodiment of the present disclosure.

FIGS. 57A and 57B illustrate a splayhook anchor plate according to anembodiment of the present disclosure.

FIGS. 58A and 58B illustrate an intracardiac device coupled to asplayhook anchor plate according to an embodiment of the presentdisclosure.

FIG. 59 illustrates an intracardiac device having a splayhook anchorplate attached to the lateral and medial papillary muscles according toan embodiment of the present disclosure.

FIGS. 60A and 60B illustrate an intracardiac device coupled to asplayhook anchor plate according to an embodiment of the presentdisclosure.

FIG. 61 illustrates an intracardiac device having a splayhook anchorplate attached to the lateral and medial papillary muscles according toan embodiment of the present disclosure.

FIGS. 62A and 62B illustrate an intracardiac device coupled to asplayhook anchor plate according to an embodiment of the presentdisclosure.

FIG. 63 illustrates an intracardiac device having a splayhook anchorplate attached to the lateral and medial papillary muscles according toan embodiment of the present disclosure.

DETAILED DESCRIPTION

An integrated implant system for restoring and improving physiologicalintracardiac flow, reducing or impairing atrioventricular pressuregradient loss or regurgitation, improving or restoring ventricularelliptical geometry and function, and providing ventricular functionaland structural support within in a human heart is provided within anintegrated vortex flow directing implant system comprising an inflatablebladder or member and/or another distal assembly or component; ananchoring system comprising a therapeutic apical base plate assemblyattachable to the heart; a tether assembly comprising a tether or shaftconnected between the implant inflatable member and the therapeuticapical base plate assembly; and a control unit attached via amulti-lumen tubing connection and implanted subcutaneously in anotherlocation.

Healthy and proper physiological intracardiac flow defined as healthycardiac structures, healthy elliptical cardiac geometry, and healthyanterior and posterior ventricular vortex formation followed by healthysystolic ejection, combining both the kinetic energy of the vortexreservoir with ventricular myocardial muscular contraction, to feed thebody with required oxygenated blood is critical to human life. The heartfunctions and moves blood in a cycle; this cycle consisting of a fillingphase called ‘diastole’ and an ejection or pumping phase called‘systole’. In the filling phase, or ‘diastole’, the ventricle is filledwith blood flowing from the atrium and through the atrioventricularvalve. This filling phase occurs naturally and is powered, inside thehuman heart by a pressure gradient called the ‘atrioventricular pressuregradient’. The atrioventricular pressure gradient is defined as apressure difference (or a pressure differential) between the chambers ofthe heart. This pressure differential produces or generates an energyand a force between the chambers of the heart, this being naturallyoccurring, naturally initiated, and naturally applied. As the pressureincreases in the atrium and pressure reduces in the ventricle, alsocalled the ‘diastolic’ phase or diastole, blood flows from thehigher-pressure atrium into the lower pressure ventricle, causing thevalve leaflets to open thereby allowing blood to pass.

During the ejection or pumping phase, also called the ‘systolic’ phaseor systole, the pressure in the atrium is exceeded by the pressure inthe ventricle thereby generating a pressure differential which, in turn,pushes up, onto, and against the valve leaflets and causes or effectsthe valve leaflets to close and seal off the ventricular chamber fromthe atrial chamber. The atrioventricular pressure gradient, then,becomes the sealing energy and force required to close the valve. Theblood is then ejected from and out of the ventricle, leaving the heartthrough the aortic valve, and out to the human body. The myocardium, orstructural muscle that makes up the human heart, contracts toward theend of the diastolic cycle and the beginning of the systolic cycle. Thiscontraction initiates the atrioventricular pressure gradient, mentionedabove, that initiates this pressure, or energy and force, which ‘closesthe valve leaflets’, which then seals the ventricular chamber closed. Inthe remaining systolic cycle, blood, under high pressure, is thenejected via muscular force aided by the healthy ventricular vortex(initiated in the diastolic cycle) to complete the hemodynamic cardiacoutput for that particular cycle. The intracardiac vortex initiates inthe diastolic phase. In ventricular diastole, the ventricular pressurerapidly decreases. The atrioventricular valve opens and the blood rushesfrom the area of higher pressure, the atrium, into the area of lowerpressure, the ventricle, through the atrioventricular valve orifice. Theatrioventricular valve leaflets, on the ventricular side of the annulus,function to steer or vector the in-flowing blood, directing it at angleor vector to create an initial spin. Such angle or vector may be due tothe asymmetry of the valve leaflets and/or to the different shapes andsizes of the leaflets. Regardless, a vortex progression results.

It is believed that the ventricular/apical counter twist, initiated indiastole, creates a bust of pressure which contacts the inflowingventricular blood, leaving the leaflets at angle or vector, and thusbegins the formation of ventricular vortex. The initial hemodynamic spinthen, facilitated and assisted by the atrioventricular pressuregradient, engages the vectored blood such that a rotational vortex iscreated. The resulting high velocity rotational flow within theventricle is believed significant to proper blood flow, cardiac output,and blood velocity enabling the blood to move throughout the humanbody's entire circulatory system. This resulting rotational flow orvortex, now a reservoir of kinetic energy within the ventricle, isbelieved significant to proper blood flow pattern, velocity and volumeduring systolic ejection. This cardiac cycle continues throughout thehuman lifecycle.

When healthy valve leaflets seal properly, the atrioventricular pressuregradient forces close the valve leaflets, seals the ventricle, andprovides a strong ventricular structure to contain and utilize theatrioventricular pressure gradient for hemodynamic ejection andstructural heart health. The papillary muscles, via the chordaetendineae, which are themselves attached to the valve's leaflets, pulland flex on the ventricle and ventricular walls thus maintaining healthyvalvular structure, healthy ventricular shape, the healthy ventricularfree wall, and healthy ventricular function (this is the heart's naturalventricular wall maintenance utilizing force transduction). This concertof interactive harmony facilitates healthy intracardiac vortical bloodflow and insures proper valvular, structural, atrial, ventricular, andmyocardial health. A cardiac insult or pathology can often initiate afailure that begins a cascade or rolling series of failures that eachfollows its predecessor. Ventricular shape change can cause the valveleaflets fail to seal, for example, and the energy and force from thisatrioventricular pressure gradient is reduced or lost. This can greatlyreduce the energy and force naturally transducted or delivered into theventricular walls via the subvalvular apparatus (the chordae tendineaand the papillary muscles) contributing to ventricular wall insult,ventricular wall stress, and shape change that adds to this cascade ofheart failure.

Cardiac insult, atrioventricular pressure gradient loss, and ventriculardisease conditions can produce geometric shape change within the valves,the ventricles and the overall heart structure which can result in flowdysfunction. This change in ventricular geometric shape can cascade intochanged flow dynamics, which in turn cause more intracardiac structuraland flow dysfunction. In certain circumstances, this dysfunction cancause the ventricles to dilate or enlarge and the valve leaflets to nolonger properly seal causing a reduction or loss of the atrioventricularpressure gradient, effectively being demonstrated by blood back-flow orregurgitant volume of fluid caused by the pressure gradient, visualizedby blood volume, forcing its way between the failing valvular seal andseen in the atrium during the ‘systolic’ phase. The system disclosedwithin, is designed, inter alia, to capture, harness, collect, andre-direct the energy and force this atrioventricular pressuredifferential creates, whether it is contained by the valve leaflets orwhether the energy and force is leaked or lost because of a failure ofthe ventricular structure, the ventricular geometry, or of the valvestructure or valve leaflets to seal. Regardless of whether the valveleaflets seal or not, the energy and force of the atrioventricularpressure gradient is captured by device contact with the nativestructures, harnessed, and contained, and then re-directed from themember or bladder, via the tethering shaft, through the apical baseplate and into the ventricular free wall, the extended apex, and theseptal wall.

In some embodiments, the integrated system includes a Vortex FlowDirecting Implant that employs the features and concepts of hemodynamicvector, atrioventricular pressure gradient loss mitigation, and forcetransduction (meaning the capture, collection, and transfer of existingnative energy & force). During ventricular contraction, considerableforces are exerted on the closed mitral valve generated by theatrioventricular pressure gradient. These forces are transducted ortransferred via the valve's leaflets, the chordae tendineae andpapillary muscles into the ventricular wall. There is a resultingvalvulo-ventricular wall interaction that provides the ventricle withstructural support by maintaining the elliptical geometry, preventingpapillary muscle displacement, and providing functional support requiredfor proper ventricular health, healthy geometric proportion, and properhemodynamic or blood ejection. During diastole, the ventricular pressurerapidly decreases. The atrio-ventricular valve opens and thehigher-pressure atrial blood rushes from the atrium into the ventriclethrough the valve orifice. The atrio-ventricular valve leaflets functionto steer or vector the blood, directing ventricular inflow at an angleor vector to create an initial spin. Such angle may be due to theasymmetry of the valve leaflets and/or to the different shapes and sizesof the leaflets and/or chordal tethering length. A ventricular vortexprogression results. It is believed that the inflowing blood leaving theleaflets at angle or at vector is critical in the formation ofventricular vortex. The initial hemodynamic spin then begins, in whichthe inflowing blood is engaged by the atrioventricular pressuregradient, and that initial spin increases such that a vortex is createddownstream. The resulting high velocity rotational flow within theventricle is believed significant to proper blood flow through the heartand of significance in delivering enough blood to the body. Theresulting rotational flow or vortex, now a reservoir of kinetic energywithin the ventricle, is believed significant to proper blood flowpatterns, velocities, and volumes through and out of the heart to thevarious reaches of the human body. By placing the member or bladder,attached to the distal end of the tether or shaft on the device,atrio/ventricularly, the Vortex Flow Directing Implant (the distalmember or bladder being this engaging component of the system) engagesand intercepts atrial blood, re-vectoring it through the valvularorifice, onto and off of the leaflets, at a vector which may be adjustedor changed, by increasing or decreasing the girth or fill of the member,to facilitate, assist, or deliver proper intracardiac vortical bloodflow.

Force transduction is defined as the intentional capture, collection orharness, and movement or transfer of native energy and force from onearea of the heart to another area of the heart. This energy and forcemay be of any natural source occurring within the human heart, be itmuscular energy and force or atrioventricular pressure gradientgenerated energy and force. The movement of this energy and force can bemechanically re-purposed and delivered as a positive restoring therapyto components or areas of the heart that have been adversely effected bypathology or cardiac insult, it is believed. By placing the Vortex FlowDirecting Implant atrioventricular manner and allowing theatrioventricular pressure gradient force to act on the exposed area ofthe implant, thus allowing the valve's leaflets to ‘grab and pull’ onthe member, the member then captures, harnesses, and moves or transfersthis atrioventricular energy and force, via the shaft, and delivers itto the ventricles, its structures, and the ventricular free walls viathe ball jointed or fixed apical base plate. The atrioventricularpressure gradient energies and forces become a restoring, mechanicallydelivered, and re-purposed essential requirement for healthy ventricularfunction. By re-creating, repairing, and assisting the native impairedvalvulo-ventricular interaction, that is the native ‘pull, flexing andrelease’ that occurs between the valve's leaflets, which are coupled tothe chordae tendineae, which are then coupled to the papillary muscles,which are finally attached to the ventricular walls with a simpleimplanted mechanical device, an effective repair is created. Thatrelationship in the impaired or diseased heart has been disrupted orlost between the impaired ventricle, the impaired valve, and theimpaired ventricular free walls. This is a mechanical re-creation, bythe device and the integrated system, of the action that the nativeventricle and heart has lost due to the pathology, disease, or injury ithas been subjected to and may be transformational in reducing theeffects of heart failure. The ‘grabbing, flexing and pulling’, moreprecisely described as atrioventricular pressure gradient forces actingon the exposed area of the member or balloon via the valve leaflet'sactions in diastole and systole, of the member by the valvular andsubvalvular structures, mechanically replaces disturbed or lost nativevalvular and subvalvular forces (driven by the systolicatrio-ventricular pressure gradient) interaction with the ventricle andventricular walls, by transducting or transferring this native force viathe tether or shaft to the therapeutic apical base plate, to and incontact with the apex, the ventricle, and the ventricular walls. Thiscreates both a structural and a functional supporting system for theweakened heart. In various embodiments, this re-instituted connection,created by restoring the connective relationship between the valve planeand the ventricle, results in a systolic ventricular structural andfunctional support increasing the ventricular ejection and cardiacoutput.

In some embodiments contained within the Vortex Flow Directing Implantand the integrated system that it is, the flow/force guiding member orbladder is the primary actuator, driver, and component in hemodynamicvector change or alteration, force transduction (meaning the capture,collection, and transfer of existing native energy & force), and in themitigation of atrioventricular pressure gradient loss or regurgitationbased on its presence within the atrio-ventricular valve structure. Inits capacity related to force transduction (meaning the capture,collection, and transfer of existing native energy & force), the memberor bladder is placed in the atrioventricular valve orifice (partially inthe atrium, distally, and partially in the ventricle, proximally) andfixed to and maintained in this location by the shaft or tether. Duringthe heart's cycle, the member or bladder is ‘grabbed, flexed, andpulled’ during systole thus allowing the atrioventricular pressuregradient force to act on and be captured by the exposed area of themember or bladder because of the contact made between the valve'sleaflets and the member or bladder. It, the member or bladder, is thenreleased in diastole because the valve's leaflets naturally open, aspart of the cardiac cycle, to allow ventricular filling. This processoccurs during every cycle that the heart completes. The opening andclosing of the valve's leaflets is naturally powered by theatrioventricular pressure gradient, the pressure lowering in ventriculardiastole and the pressure then increasing in ventricular systole. Themember or bladder captures, harnesses, and transfers or moves thisatrioventricular pressure gradient energy and force. captured on theexposed area by being ‘grabbed, flexed, and pulled’ in ventricularsystole by the valve's leaflets, and then, via the tether/shaft and thenvia apical base plate, this native energy and force is passed onto anddelivered into the ventricle and its structures, the septal wall, andthe ventricular free walls thereby re-creating, mechanically, theimpaired or lost natural valvulo-ventricular interaction. Thevalvulo-ventricular interaction, or the healthy natural relationship inwhich the valve's leaflets, attached to the chordae tendineae and thepapillary muscles, is naturally used by the human heart to maintain thehealth, geometric elliptical shape, and compliance of the ventricle, thevalve, and the ventricular free wall. This valvulo-ventricularrelationship is then re-created mechanically with the Vortex FlowDirecting Implant and the native energy and force found within theatrioventricular pressure gradient and is used and delivered as aventricular restoring therapy to restore the impaired or lostventricular structural maintenance the heart requires for healthyfunction. A failure of the valve leaflets to properly seal creates aleakage or loss of this atrioventricular pressure gradient. As thepressure gradient leaks, as evidenced by fluid or blood, back into theatrium from the ventricle, native energy and force is lost or diminishedand this condition can lead to ventricular dysfunction and ventricularfree wall dysfunction. In this case, the member or bladder, simply byits presence in the atrioventricular valve orifice, may act as atemporary seal or plug to reduce or cease this pressure gradient loss.The member or bladder itself just being present may accomplish this. Itspresence in the atrio-ventricular orifice may reduce, slow, or impairthe atrioventricular gradient loss that can occur. Additionally, invarious embodiments, (a member within a member or balloon within aballoon), created by fitting of an ‘inflatable belt’ around the memberor bladder such that the ‘inflatable belt’ runs around the member, as aprotective belt, along the ‘commissural line’, meaning the line acrosswhich the valve's leaflets would naturally fall upon when they areclosed or sealed during the systolic cycle. The native valve's leafletsseal along this ‘line of commissure’, as they naturally fall and arrestin this position, but the valve's leaflets may now, additionally, sealor seat themselves against this ‘inflatable belt’. As the ‘inflatablebelt’ is filled with fluid, gas, or another material, the topography ofthe leaflet edges may conformed to and seal against the inflatable belt,thereby reducing or stopping the atrioventricular pressure gradientleakage and therefore the loss of energy and force needed for healthyheart structure and function.

In various embodiments, the mitigating, sealing, and/or plugging of aleak of the atrioventricular pressure gradient in or around the valveleaflets may be accomplished with a semi-lunar shaped, malleable yetrigid, ‘manta’ or other shaped member or bladder, being solid on theposterior half and inflatable on the anterior portion. This may bereversed as well, meaning the posterior half is inflatable and theanterior portion is solid. The member or bladder being solid and in asemi-lunar shape on the anterior side, in this case, and inflatable onthe posterior side allows the posterior leaflet edges to betopographically conformed with or to and then enables them to sealagainst this inflatable balloon on the posterior side.

In various embodiments, a Dual Force Pressure Mitigating Implant (anintegrated system embodiment with the added ‘one way valve’ or ‘checkvalve’ and a pressure mitigating assembly or ‘skirt’ and utilizing thesame shaft or tether, ball jointed apical baseplate or fixed baseplate,and control unit) has one or more contact points in the heart. The DualForce Pressure Mitigating Implant is created by combining the ‘one wayvalve’ or ‘check valve’ and the pressure mitigating assembly or ‘skirt’which then becomes the distal attachment to the shaft or tether, fixedto the apical ball jointed baseplate or fixed base plate, and controlunit connected by the multi-lumen tubing. The Dual Force PressureMitigating Implant is positioned and fixated on the inflow or atrialside of the native or prosthetic valve and is rigidly fixed in locationby the integrated system's shaft or tether which connects to the balljointed apical baseplate or a fixed baseplate. The Dual Force PressureMitigating Implant is, in effect, a ventricular and valvular functionalassist device that is placed above an atrioventricular native orprosthetic valve and assists the native or prosthetic valve inmitigating atrioventricular pressure gradient loss, preservingventricular shape and function loss by connecting the valve plane to theapex of the heart thus applying force transduction (meaning the capture,collection, and transfer of existing native energy & force) into theventricular structures, and ventricular walls, functioning as aventricular assist device by loading the spring like structural housing(the framework of the pressure mitigating assembly) with energy & forcein diastole (as the heart elongates and stretches that energy & force iscaptured and retained in the spring-like structures) and releasing theenergy during systole without causing or creating any changes to thenative anatomy within the human heart. The Dual Force PressureMitigating Implant can be a temporary or a permanent solution to theimpaired valve, diseased ventricle, diseased ventricular structures, andimpaired ventricular walls. In some embodiments, the distal suspensionring and proximal annular structural supports/rings or components arenitinol, elastic, expandable, and/or rigid so that the pressuremitigating assembly or ‘skirt’ may be expanded to mitigate, catch, andretain any atrioventricular pressure loss caused by the native orprosthetic valve's leaflets failing to maintain a seal. Any regurgitatedblood is captured and retained inside the pressure mitigating assemblyor ‘skirt’ and returned to the ventricle as the diastolic or ventricularfilling phase occurs.

Connected or fixed to the distal suspension ring and the proximalannular ring and housed within the pressure mitigating assembly or‘skirt’, is the ‘one way valve’ or ‘check valve’ that allows blood toflow in one direction through it from the atrium, through said ‘one wayvalve’ or ‘check valve’, and into the ventricle. The ‘one way valve’ or‘check valve’ prevents the atrioventricular pressure gradient,demonstrated by the regurgitant blood flow, from leaking orregurgitating back from the ventricle and returning into the atrium. The‘one way valve’ or ‘check valve’ is rounded and may or may not conformto the valve's annulus and/or the valves annular anatomy. The pressuremitigating assembly or ‘skirt’ is framed and structured by the expansionof the nitinol, elastic, expandable, and/or rigid material and thegradient funneling ‘skirt’ is constructed of a polymer and/ornon-thrombotic material. The distal portion of the Dual Force PressureMitigating Implant structure consists of two components; the ‘one wayvalve’ or the ‘check valve’, which mitigates the atrioventricularpressure loss or regurgitation, and the pressure mitigating assembly,which is the housing, the mount, the structural and locationalstability, and the anchor point for the ‘one way valve’ or ‘check valve’fixed inside of it. The pressure mitigating assembly frame structurealso supports the gradient funneling skirt by positioning it, providingits form, and holding it in place securely. In its dual force capacity,the nitinol, and/or elastic, expandable, spring like struts load thepreload force generated by the elongation and filling of the ventriclein diastole and release it as spring loaded energy & force in and duringsystole. In this capacity, the Dual Force Pressure Mitigating Implantprovides ventricular functional and ejectional support in addition toamplified force transduction (meaning the capture, collection, andtransfer of existing native energy & force) of atrioventricular pressuregradient into the ventricle, ventricular structures, and ventricularwalls. This function is not impacted negatively by the completedassembly of the Dual Force Pressure Mitigating Implant because the frameis spring-like and conformal. It contains, houses, and positions a ‘oneway valve’ or ‘check valve’ with a ‘duck bill’, the open end or distalend oriented toward the atrium and the closed or billed end orientedproximally toward the ventricle. This orientation allows pressurizedblood to pass through the ‘one way valve’ or ‘check valve’ from theatrial/distal side and move through the ventricular/proximal ‘bill’ andinto the ventricle. Pressurized blood attempting to return from theventricle back into the atrium is stopped and/or prevented by the closed‘one way valve’ or ‘check valve’ proximal end ‘duck bill’ and thisregurgitant blood volume is contained within the skirt on the atrialside of the native or prosthetic valve or within the ventricle. Itshould be noted that this Dual Force Pressure Mitigating Implant may beused as a preventative measure and not just as a reparative measure totreat the ventricle and its structure and not just a failing orcompromised native or prosthetic valve. The Dual Force PressureMitigating Implant continues to act as a systolic ventricular assist andforce transducting (meaning the capture, collection, and transfer ofexisting native energy & force) device by itself, remaining tethered tothe apex via the shaft and via the apical base plate, and can bedistally self-expanding and/or self-forming. In diastole, theatrioventricular pressure gradient functions normally, allowing pressureto freely pass into the ventricle through the ‘one way valve’ or ‘checkvalve’. In systole, the ‘duck bill’, by facing proximally or orientedtoward the ventricle, is sealed and closed by the atrioventricularpressure gradient and the energy & force is contained within theventricle by the sealing ‘duck bill’ secured on the atrial side of thevalve annulus which thus prevents any backflow or loss of the pressuregradient. This cycle continuously repeats itself. Due to the positioningand fixation of the device, The Dual Force Pressure Mitigating Implantdoes not interfere with the valve leaflets, the valvular substructure,or any of the valves components allowing for complete freedom ofmovement of all of these structures.

In some embodiments, the Dual Force Pressure Mitigating Implant can beattached to the tether or shaft with or without a coapting member orbladder placed on the tether or shaft along the line of coaptation. Insome embodiments, the annular structural components may control theshape of the atrium around the valve annulus. In some embodiments, theannular structural components may control the shape of the nativeannulus of the heart. In some embodiments, the Dual Force PressureMitigating Implant is fixed on the inflow side of a valve, by a tetheror shaft, in the atrium. In some embodiments, the structural componentson the inflow side are in contact with the annular structure. In someembodiments, the Dual Force Pressure Mitigating Implant's structuralcomponents stabilize the device, center the device, the dual forcecomponents transduct (meaning the capture, collection, and transfer ofexisting native energy & force) an increased force to the apex,structures of the heart, ventricles, and the ventricular walls, and aidin the geometric re-shaping of the ventricle, the reverse remodeling ofthe ventricles, strengthening the ventricular walls, and assisting inventricular ejection and add a constant amount of cinching force andsupporting structure by tethering or anchoring the annulus to the apexof the heart. In some embodiments, the annular structural components arefixed in location, in contact with, and attached to the annularstructure of the valve, and/or shape and/or re-shape the valve annulusand/or the atrium. In some embodiments, the laterally extending strutsare elastic and/or spring-based to absorb, store, recoil, and transferenergy into the endocardium, myocardium, and epicardium via the shaftand an attached base plate. In some embodiments, the laterally extendingstruts are elastic, nitinol, spring-like, and/or another expandablematerial designed to absorb, preload, return, and “launch” nativecardiac energy and force. This force and energy is ‘loaded’ in thediastolic phase, held within this spring-like material, and released or‘launched’ in this systolic phase. This facilitates and enablescompounded energy and targeted force to be generated thereby furtherenhancing, facilitating, and creating the conditions for rapidventricular positive or reverse remodeling.

In various embodiments, a Dual Force Annular Implant (an integratedsystem embodiment) is described and defines a dual force annular haloband, “D”-shape and/or saddle shape and/or circular and/or oval shape,of nitinol or a spring-like material purposed to connect the valve planewith the apex, fixed to a connecting shaft running though the ventricleand secured to the apex of the human heart, to impart or transduct(meaning the capture, collection, and transfer of existing native energy& force) the forces of the atrioventricular pressure gradient into theventricle, the ventricular structures, and the ventricular walls.Connected to the self-expanding structure and/or the annular ring calledthe dual force annular halo, the Dual Force Annular Implant device, issimply a force transducting device that loads energy & force in diastoleand releases this preloaded energy & force in systole. The Dual ForceAnnular Implant, acting as a force transducting (meaning the capture,collection, and transfer of existing native energy & force) therapy byitself, assembles the dual force annular halo, which is self-expanding,nitinol or spring-like, and/or self-forming and compounding ventricularsystolic assist functioning by loading force in diastole and releasingthis loaded force in systole, fixed to a shaft or tether, which is thenfixed to the ball jointed or fixed baseplate. The dual force annularhalo structure can be used as an annular re-shaping device atransducting structure, and as a structural foundation and mount forvalve plane to apex connection purposed to transfer native energy andforce from one point directly to another. In some embodiments, bothacting as a force transducting (meaning the capture, collection, andtransfer of existing native energy & force) agent and a forcecompounding agent, within the atrium and the ventricle, connectivefunction of tying the valve plane to the apex of the heart serves to actas an additional or prosthetic papillary muscle transducting and/ormoving atrio-valvulo energy & force to the ventricle, the ventricularstructures, and the ventricular walls.

In various embodiments, a Dual Force Pressure Coapting Implant (anintegrated system embodiment with the added ‘one way valve’ or ‘checkvalve’ and a therapeutic fixation assembly and utilizing the same shaftor tether, ball jointed apical baseplate or fixed baseplate, and controlunit) is described and has one or more contact points in the heart. TheDual Force Pressure Coapting Implant is created by combining the ‘oneway valve’ or ‘check valve’ and the therapeutic fixation assembly whichthen becomes the distal attachment to the shaft or tether, fixed to theapical ball jointed baseplate or fixed base plate, and control unitconnected by the multi-lumen tubing. The Dual Force Pressure CoaptingImplant is positioned and fixated on the inflow or atrial side of thenative valve and is rigidly fixed in location by the integrated system'sshaft or tether which connects to the ball jointed apical baseplate or afixed baseplate. The Dual Force Coapting Implant is, in effect, aventricular and valvular functional assist device in which thetherapeutic fixation assembly which is placed above an atrioventricularnative valve and the ‘one way valve’ or ‘check valve’ proximal portion,which the therapeutic fixation assembly houses and structurallysupports, is fixated in the valve orifice, between the anterior andposterior valve leaflets along the line of coaptation, and assists thenative valve in mitigating atrioventricular pressure gradient loss,preserving ventricular shape and function loss by connecting the valveplane to the apex of the heart thus applying force transduction (meaningthe capture, collection, and transfer of existing native energy & force)into the ventricular structures, and ventricular walls, functioning as aventricular assist device by loading the spring like structural housing(the framework of the pressure mitigating assembly) with energy & forcein diastole (as the heart elongates and stretches that energy & force iscaptured and retained in the spring-like structures) and releasing theenergy during systole without causing or creating any changes to thenative anatomy within the human heart. The Dual Force Coapting Implantcan be a temporary or a permanent solution to the impaired valve,diseased ventricle, diseased ventricular structures, and impairedventricular walls. The therapeutic fixation assembly may be expanded tomitigate, catch, and retain any atrioventricular pressure loss caused bythe native valve's leaflets failing to maintain a seal or any loss thatmay get around the ‘one way valve’ or ‘check valve’ in the commissuresof the native valve. Any regurgitated blood is captured and retainedinside the therapeutic fixation assembly and returned to the ventricleas the diastolic or ventricular filling phase occurs. The therapeuticfixation assembly contains, houses, and positions a ‘one way valve’ or‘check valve’ with a ‘duck bill’, the open end or distal end orientedtoward the atrium and the closed or billed end oriented and fixatedwithin the valve, between the valve's leaflets, proximally toward theventricle. This orientation allows pressurized blood to pass through the‘one way valve’ or ‘check valve’ from the atrial/distal side and movethrough the ventricular/proximal ‘bill’ and into the ventricle.Pressurized blood attempting to return from the ventricle back into theatrium is stopped and/or prevented by the closed ‘one way valve’ or‘check valve’ proximal end ‘duck bill’ and this regurgitant blood volumeis contained within the skirt on the atrial side of the native valve orwithin the ventricle. It should be noted that this Dual Force PressureCoapting Implant may be used as a preventative measure and not just as areparative measure to treat the ventricle and its structure and not justa failing or compromised native valve. The Dual Force Pressure CoaptingImplant continues to act as a systolic ventricular assist and forcetransducting (meaning the capture, collection, and transfer of existingnative energy & force) device by itself, remaining tethered to the apexvia the shaft and via the apical base plate, and can be distallyself-expanding and/or self-forming. In diastole, the atrioventricularpressure gradient functions normally, allowing blood to freely pass intothe ventricle through the ‘one way valve’ or ‘check valve’. In systole,the ‘duck bill’, by facing proximally or oriented toward the ventricle,is sealed closed by the atrioventricular pressure gradient and theenergy & force is contained within the ventricle by the sealing ‘duckbill’ secured on the atrial side of the valve annulus which thusprevents any backflow or loss of the pressure gradient. This cyclecontinuously repeats itself. Due to the positioning and fixation of thedevice, The Dual Force Pressure Coapting Implant does not interfere withthe valve leaflets, the valvular substructure, or any of the valvescomponents allowing for complete freedom of movement of all of thesestructures.

The described embodiments, as an integrated system, are all implanted ina minimally invasive transapical manner. The transapical procedurecommonly consists of gaining access to the apex of the heart through athoracotomy. This is a standard, common, routinely used surgical accessprocedure utilizing standard transapical access technique, that beingdefined as an apical retrograde approach, accessing the ventricle andthe atrioventricular valve with commonly used standard surgical, andmedical techniques. Once the apex is visualized, a means of controllingthe access site either via purse string suture and pledget or through anapical closure device that allows working access through the devicewhile controlling the apex or access site is utilized. A needle is thenused to insert a guidewire into the ventricle of the heart. Theguidewire is held in place and the needle is then exchanged down thewire. A valved introducer sheath and dilator are introduced over thewire and used to dilate and created a sealed access site at the apex ofthe heart. Using either echocardiography or fluoroscopy or a combinationfor visualization, the sheath, dilator and guidewire are steered ormaneuvered around the papillary muscles and chordae, across theatrioventricular valve, retrograde, or against the flow of blood, andinto the atrium. The imaging is used to avoid entanglement with thesubvalvular structures and to use as guidance as to where theimplantation components are in the heart. Once in the atrium theguidewire and dilator can be removed from the sheath. The sheath is nowa guiding “tunnel” from external to the apex to the atrium. The implantafter having been flushed to remove air, crimped, compressed, folded orotherwise prepared is passed through the valve and into the body of thesheath. The implant is advanced until it begins to protrude out of theend of the sheath. The location is confirmed, and the implant can bedeployed either in the atrium and pulled into position or deployedpartially in the atrium and pulled into the valve orifice as the sheathis retracted. Once fully deployed, the implant is put into or maneuveredinto a final placement. The sheath is removed while simultaneously theapical closure device is synched down to control bleeding. The sheath ispulled off of the tubing and a baseplate is put on and slide up to theapex. The implant can be tuned for the axial placement and the baseplatelocked to secure its location in the heart. If the implant has tubingleading from the heart this is lead out through the incision site. Asmall incision is made at an appropriate site for the subcutaneouscontrol unit to be placed. A pocket formed in the tissue and the tubingis tunneled to the site for the subcutaneous control unit. The tubing isthen connected to the control unit. The system is now fluidicallyconnected and can have a final flush via the control unit access sites.Typically, a non-coring needle is used to puncture into the control unitto adjust or dial in the level or amount of force transduction therapyor final flow vector volume of the device.

The described embodiments may also be implanted in a true transcathetermanner. The transcatheter method of implant is less invasive and bettertolerated by patients. Additionally, the anesthesia required issignificantly less and, this being the most dangerous part of anymedical procedure, is highly conducive to better patient outcomes. Atranscatheter procedure utilizing standard transcatheter approaches,defined as transfemoral, transvenous, and transjugular, and standardtranscatheter techniques, may be used to implant all of the embodimentsof the integrated system. The access site to the blood vessel may bethrough any clinically relevant location with the primary locationsbeing a percutaneous femoral vein access, a subclavian access, or ajugular access. The access site is prepared with standard cardiaccatheterization laboratory procedures with the Seldinger technique usedto access the vessel of choice. An introducer sheath is then insertedinto the vessel. Through the sheath, a guidewire, dilator, and steerableor preformed sheath is used to guide the distal end of both theguidewire and the sheath to the fossa ovalis. The sheath, dilator andguidewire can be maneuvered easily to the fossa ovlis under fluoroscopyor echocardiography imaging. The fossa ovalis is a naturally occurringdepression in the right atrium in the interatrial septal wall and is acommon, well known, standard anatomical landmark known to medicalprofessionals. By puncturing the thin membrane covering over the fossaovalis, the left atrium can be accessed from the right atrium. Varioustechniques exist for puncturing the membrane including a needle, aBrockenbrough needle, a radio frequency catheter, and or the sharpenedguidewire are commonly used. Once the septum is punctured the site canbe dilated up, or enlarged, to accommodate the implant or devicedelivery sheath size and to place the sheath inside the left atrium. Thetranseptal puncture allows access to the left atrium and the sheath isthen guided, antegrade (meaning in the direction of blood flow), throughthe mitral or atrioventricular valve and into the left ventricle. In theleft ventricle the papillary muscles are visualized. The sheath isdirected or steered in between the lateral and medial papillary musclesand the advance is then stopped. A universal splayhook anchor plate isfully extended from the distal end of the introducing sheath, thatextension stopping at the universal ball mount, the point at which theuniversal shaft receiver is coupled to the shaft. The shaft and memberor distal integrated system attachment still remains housed within thedelivery sheath and is connected and coupled to the universal splayhookanchor plate. The universal splayhook anchor plate is an anchoringmechanism or component with two sharpened and barbed anchor pointedwires, hook shaped with memory, extending from central universal ballmount, in a reverse taper, the wires crossing proximally to the barbeddistal ends, which splay and open under direct pressure, thus allowingthe papillary muscle to pass though the splayed or opened channel. Thewires then close from memory immediately after the papillary musclepasses and the tension created between the connection at either end ofthe universal splayhook anchor plate, the lateral papillary muscle onone end and the medial papillary muscle on the other end, cause thesplayhooked barbed anchor points to press in, anchor, and seat properlyinto the respective papillary muscles. The introducing sheath is thenretracted, from the universal splayhook anchor plate, at the universalball mount, and the shaft with the integrated system distal attachmentor member is deployed or released from the introducing sheath. Theintegrated system distal attachment or member is deployed or released inposition, either within the atrioventricular valve orifice or on theatrial annulus, depending upon the embodiment being implanted. Themulti-lumen tubing is lead from the atrial side of the implant throughthe fossa ovalis and to the jugular access site. Near the access site asmall incision is made at an appropriate site for the subcutaneouscontrol unit to be placed. A pocket is formed in the tissue and thetubing is tunneled to the site for the subcutaneous control unit. Thetubing is then connected to the control unit. The system is nowfluidically connected and can have a final flush via the control unitaccess sites. Final adjustments can then be made to the implanted systemvia the hydraulically adjustable shaft. Typically a non-coring needle isused to puncture into the control unit to adjust or dial in the level offorce transduction therapy or final fill volume of the device.

One of the features of healthy human heart, as shown in FIG. 1, functionis proper physiological intracardiac flow defined as healthy cardiacstructures (1)(2)(3)(7)(11), healthy elliptical cardiac geometry(3)(4)(5)(6), and healthy anterior and posterior ventricular vortexformation followed by healthy systolic ejection, combining both thekinetic energy of the vortex reservoir with ventricular myocardialmuscular contraction, to feed the body with required oxygenated blood.During the heart's natural pumping cycle, diastole and systole, forcesare naturally generated causing the valve leaflets (7) (12) (13) to openand close with considerable forces exerted on the closed or sealedatrial/ventricular leaflets (12) (13) and valve (7), especially duringsystole. This natural force is defined as the atrioventricular pressuregradient. This atrioventricular pressure gradient and the energy andforce it delivers are critical in maintaining valvular(7)(8)(9)(10)(12)(13) and ventricular (3)(4)(5)(6) health and function.Geometric functional stability and ventricular function is maintained byimparting this energy and force (the energy and forces of theatrioventricular pressure gradient), into the ventricular walls (4) (6),septal wall (6), and apex (5) to maintain the healthy ventricle (3), tomaintain the structures of the ventricle (3) (4) (5) (6), to maintainthe structures of the valve (7)(8)(9)(10)(11), and provide for dynamicproper physiological hemodynamic ejection. Failing, diseased, orimpaired cardiac structures, be they valves (7) or valvular components(8)(9)(10)(11)(12)(13), the heart itself (1), the ventricular free wall(4), or the septal wall (6) can have a cascading effect that results inthe loss of proper physiological intracardiac flow and the loss oftransducted forces into the structures of the heart(4)(6)(8)(11)(12)(13) which require these imparted forces to maintaincontinued health and function. This native energy and force is deliveredto the structures that require it by a naturally occurring process. Inthe healthy heart, via the closing of the valve leaflets (12)(13) andthe pulling of the subvalvular apparatus (11) and structures (8)(5)(6)in reaction to this atrioventricular pressure gradient, this energy andforce is passed, moved, or transducted via the chordae tendineae (9) andpapillary muscles (10) and into the ventricles (3), the septum (6), andventricular walls (4). This resulting valvulo-ventricular interactionkeeps the ventricular structure (3)(4)(5)(6) healthy and provides theventricle (3) with the structural support to maintain the properelliptical ventricular geometry and functional shape. Geometricstability and ventricular function is maintained, in an impaired ordiseased heart, by imparting, mechanically via the Vortex Flow DirectingImplant (100) and an integrated system (100)(600)(619)(700)(800)(900),the atrioventricular energy & force into the ventricular walls, theprocess called ‘force transduction’, to maintain the healthy ventricle(3), to maintain the structures of the ventricle (3)(4)(5)(6), tomaintain the structures of the valve (7)(8)(9)(10)(11), and provides fordynamic proper hemodynamic ejection and vortical flow.

In an impaired ventricle, as shown in FIG. 2, in this case a dilatedcardiomyopathy, this delivery of energy and force is compromised bycardiac insult and/or pathology. The structure of the ventricle (3) thenbegins to lose its elliptical shape and geometry, and/or the valve (7)fails to seal and maintain the pressure of the AV pressure gradientwithin the ventricle. The result is a reduction or loss of theatrioventricular pressure gradient, energy and force required tomaintain healthy elliptical geometry and cardiac structure, and areduction or loss of proper hemodynamic vortical flow. This AV pressuregradient is then reduced or lost to regurgitation or backflow throughthe impaired valve (7), and it results in a loss of energy and force asthe regurgitant volume is forced back from the ventricle (3) and intothe atrium (2). This can cause a cascade of negative events such as theloss of intracardiac vortex and vortical flow, geometric shape loss(1)(3), negative remodeling of the ventricle (3) and ventricularstructure (3) (4) (5) (6), valvular (7) regurgitation, and othernegative symptoms that will continue to worsen in the native humanheart. This device (100), as shown in FIG. 6 impedes this negativeprocess and mechanically restores the ventricular function as itre-vectors blood entering and exiting the valve (7) and valvular orificeas it flows onto and off of the leaflets (12)(13), assists in therestoration of proper vortical formation and flow, captures theatrioventricular pressure gradient energy and force, stops theatrioventricular pressure gradient loss, and delivers this energy andforce to an apical base plate (300), either ball jointed (301) or not,and then via the apical base plate (300), delivers this native energyand force into the ventricle (3), the ventricular structure (3)(4)(5),the septum (6), and the ventricular free walls (4). A system isdescribed that addresses this complex pathology.

Vortex Flow Directing Implant—The Vortex Flow Directing Implant (100),one device within an integrated system (100)(600)(619)(900), withseveral composite functions, parts, and/or aspects. The device consistsof member (110) within a member (110) and/or a multi chamber fluidfilled member (110) which is described as an inflatable flow/forceguiding unit or member (110), a multi lumen (208) transducting fixedtether or shaft (200) which may be axially adjustable (202)(204) as acomplete assembly (200), the assembly transitioning into an inner fixedtether or shaft (204) and an outer axially moving tether or shaft (202),which may be adjusted distally or proximally at any time, the outeraxially moving tether or shaft (202) harboring an integrated inflatableaxially adjusting balloon (206), which may be inflated, deflated, oradjusted at any time, with the whole of the tether or shafttransitioning (207) into a multi lumen tube (400) after exiting the apex(5). The tether or shaft (200) is fixed to the apex (5) of the heart bya base plate (300), either ball jointed (301) or not and may have apiston (307) which adjusts the tether or shaft (200) for axial height(204), initially mechanically secured onto the apex (5), and then aftertransitioning into a multi lumen connective tube (400), to a controlunit (500) that may in some embodiments house or harbor intracardiacsensoring components, adjusts the device orientation and performance viaa fluid communicating system when connected (506) to the multi lumentube (400).

The member (110) may have any shape, including a manta shape (120) that,FIGS. 8 & 10 with its ‘wings’ (115), may intercept, vector, and redirectblood flow from the atrium (2) to the ventricle (3), that manta shape(110) being larger with its ‘wings’ (115) in the atrium (2) and taperingsharply (118) (119) in the ventricle (3). The member (110) may in someembodiments harbor a latitudinal (‘wing to wing’) shape supportstructure (117)(116) a skeletal crescent beam with lumen (116) fixed tothe distal end of the axially moving shaft (202) with twoforce-transducting trusses (117) connecting to the proximal end of theaxial moving shaft (202) inside of the member (110) to aid in thehemodynamic interception, hemodynamic vector, and transduction (meaningthe capture, harness, transfer, and movement of this energy and force)of captured atrioventricular energy and force (AV pressure gradient) andmechanically does two things: the member (110), in any shape, or in themanta shape (120) intercepts atrial (2) blood and re-vectors (111) it toassist, enhance, or restore the vortex, vortical flow, and naturalphysiologic blood flow vector passing blood over, across, and off of thevalve leaflets and into the ventricle (3) and it captures (112) thenative atrioventricular pressure gradient, or the ventricular energy andforce, utilizing the valvular (12)(13) and subvalvular structures (11)as they coapt or seal (12)(13)(112) and thus ‘grab, flex, and pull’(112) on the member (110) in systole. The ‘grabbing, flexing, andpulling’ (more precisely described as atrioventricular pressure gradientforces acting on exposed area of the member (110) at the line ofcoaptation (112)) by the valvular (7)(12)(13) and subvalvular structures(9)(10)(11), mechanically replaces and imparts the disturbed or lostnative valvular and subvalvular force (driven by the systolicatrioventricular pressure gradient) interaction with the ventricle (3),the ventricular structures (4)(5)(7), the septal wall (6), andventricular walls (4) by transducting, meaning the capture, collection,and transfer of existing native energy & force, this native force viathe apical base plate (300), to and in contact with the apex (6), theventricle (3), ventricular structures (4)(5)(6)(7), and ventricular wall(4). This is one systemic function and/or aspect of this device withinan integrated system.

The member (110) intercepts, steers, re-directs, and/or FIGS. 8, 9, 10changes hemodynamic vector of the blood flowing onto and off of valvularleaflets (7)(12)(13). Flow channel’ creating ribs (111) running at angle(114) along the surface of the member (110) steer the intercepted flowof blood onto and off the valve leaflets (12) (13), and facilitatesproper vector (111) (12) (13) upon entry into the ventricle (3). Thishemodynamic re-vector (110) (114) (111) (12) (13) mechanically restores,enhances, and/or assists the natural physiologic vector therebyfacilitating the enhancement, restoration, and/or re-creation ofventricular vortex, critical to physiologic healthy flow. This is onesystems function and/or aspect of this device within an integratedsystem.

The valvular leaflets (12)(13) and FIG. 3, 4 subvalvular structures(9)(10)(11) ‘grabbing, flexing, and pulling’ (112) of the member (110)mechanically replaces lost valvulo-ventricular interaction FIG. 11 bytransducting, meaning the capture, collection, and transfer of existingnative energy & force, this native force via the apical base plate (300)which FIG. 14 then, by connection via the tether or shaft (200) to andcontact with the apex (5), ventricle (3), and ventricular wall (4),either utilizing specific edge shapes (305) or not, delivers thisphysiologic produced natural energy and force (atrioventricular pressuregradient energy and force) into the ventricular structure (3)(5)(6)(4)thereby inducing reverse remodeling (positive geometric reshaping) ofthat ventricular structure (3), valvular structure (7), and cardiacstructure (1). There is a resulting valvulo-ventricular (7) (3)(4) wallinteraction that provides the ventricle (3) with structural support bymaintaining the elliptical geometry (1)(3)(4), preventing papillarymuscle (10) displacement, and providing functional support required forproper ventricular health, healthy geometric proportion, and properhemodynamic or blood ejection. This is one systemic function and/oraspect of this device within an integrated system.

The loss of any portion of the atrioventricular pressure gradient cancause serious cardiac (1), ventricular (3), and valvular (7) pathologyand compromise this native energy and force. The preservation of theatrioventricular pressure gradient, by preserving geometric cardiac (1)and ventricular shape (3) and valvular structure (7) may be important toventricular (3) and overall health. This atrioventricular pressuregradient, its energy and force, and its positive resulting ventricular(3) and valvular (7) health effects can be mechanically preserved byplacing, fixing, and/or securing the member (110) within theatrioventricular valvular orifice (16). The member (110), while thevalve leaflets (12) (13) simultaneously capture (112) and harness theenergy and force of the atrioventricular pressure gradient by surfacearea contact between the valve leaflets (12)(13) and the member (110),may in some embodiments seal the ventricle (3) by facilitating thesealing of the ventricle (3) by the valvular leaflets (12) (13)topographically sealing to the member (110) at the point at which theycome into contact (112) with the member (110). This sealing contact(112), whether complete or not and occurring because of the merepresence of the member (110) in the atrioventricular valvular orifice(16), does slow or impede the loss of the atrioventricular pressuregradient in the presence of a compromised or failing native orprosthetic valve. The mere presence FIGS. 10 & 11 of the member (110)may in some embodiments be sufficient to preserve the ventricularpressure of the atrioventricular pressure gradient. Pressure beingindependent of volume, the member (110) is placed(7)(12)(13)(14)(15)(16) to obstruct, reduce loss, or stop some or all ofthe systolic atrioventricular pressure gradient loss to thus preservethe energy and force of the atrioventricular pressure gradient, while atthe same time transducting or transferring the required energy and forceinto needy cardiac structures (3)4(5)(6)(7)(8), and thus, maintainmaximum efficiency of the cardiac cycle. The regurgitant volume, or theblood flowing back through the valve leaflets (12) (13) and into theatrium (2) from the ventricle (3), is the loss of the atrioventricularpressure gradient visualized.

The mechanical movement and use of this native gradient energy and forceto repair, restore the native elliptical shape (3), or geometricallyreshape (reverse remodel) the ventricle (3), the ventricular structures(3) (5) (6) (4), and ventricular walls (4), while simultaneouslyreducing, stopping, and/or impeding atrioventricular pressure loss, isan integrated systemic function common to all embodiments. Theatrioventricular pressure gradient energies and forces, through thedevice (100), become a restoring, mechanically delivered, andre-purposed essential requirement for healthy valvular (7) andventricular function (3)(4). This is one systemic function and/or aspectof this device as an integrated system.

The fixed ball jointed (301) apical base plate (300)(302), with roundoval cutouts (306), may in some embodiments FIGS. 14, 15 have an axialtether or shaft (200) adjusting piston (307) which is hydraulicallycontrolled (308) and in communication via the FIG. 16 multi-lumen tubing(400) with the control unit (500), to allow fibrous tissue in-growth(306) for long term security, pulls the apex (5) upward in systole andreleases the apex (5) in diastole and, in conjunction with the elongated(305) therapeutic extensions of the ball jointed (301) apical base(300)(302) plate extending up the sides of the ventricles (3), impartsby contact (300)(305), specific shape (305), and fixation(200)(300)(302)(306) this mechanically transducted or transferred energyinto the ventricles (3). This induces a physiologic and therapeuticresponse by mechanically replacing the lost valvulo-ventricularinteraction (11)(3)(4) required to maintain a healthy ventricle (3),ventricular free wall (4), and a healthy geometric ellipticalventricular (3)(4)(6) shape. The control unit (500) has FIG. 17 threeindependent vertical contained chambers (501,502,503) and twoindependent horizontal contained chambers (504)(505), each identifiablebelow the skin by palpable protrusions, one palpable vertical protrusionfor chamber one (501), two palpable vertical protrusions for chamber two(502), three palpable vertical protrusions for chamber three (503), onepalpable horizontal protrusion for chamber four (504), and two palpablehorizontal protrusion points for chamber five (505), with a multi-lumensingle connection point (506) placing the control unit (500) incommunication, via the shaft (200), with the member (110), and has aneedle access pad (500) of ePTFE or any other material, which may insome embodiments allow fibrous tissue in growth. In one verticalchamber, fluid is introduced or removed to increase or decrease themember (110) girth or width. Increasing or decreasing this member girthalters the vector of blood and adjusts (112) the amount of forcecaptured and transducted to the ventricle (3) by increasing ordecreasing the surface area contact of the valve's leaflets (12)(13) onthe member (110) along the commissural line or line of coaptation (112).In one vertical chamber, fluid is introduced or removed from theintegrated inflatable axial adjusting balloon (206) to increase ordecrease (202) the axial positioning shaft (202) of the member (110) asreverse re-modeling (3) occurs and to remove excess ventricular bloodvolumes (206) in specific cases such as dilated cardiomyopathy. In onevertical chamber, fluid is added or removed to create crescent shapedarticulation (117)(115) in the member (110) ‘wings’ (115), eitheranterior or posterior, to better vector the intercept of atrial (2)blood by introducing fluid into the ‘wing’ chambers (117) via theskeletal crescent beam with lumen (116). In both horizontal chambers(504,504) sensoring communications power, data storage, or equipment maybe housed. This is all one systemic function and/or aspect of anintegrated device as a system.

Sensoring nodes may be placed at any location within the member (110),within or on any component(100)(200)(300)(400)(500)(600)(619)(700)(800)(900), within or on anystructure (1), and/or anywhere on this integrated system thereby usingthe inflatable member (110), the shaft (200), the apical base plate(300), the multi lumen tubing (400), the control unit (500) and/or anyand all other added part or parts (100)(200)(300)(400)(500) of thesystem as an intracardiac sensoring harbor' for intracardiac sensoringcomponents and nodes. In some embodiments, these sensors may be indirect or indirect contact and communication with the control unit (500)via FIG. 16, 17 the multi-lumen tubing (400). These harbored sensors mayin some embodiments collect, store, and report to an external device allinformation and data that is collected, monitored, and gathered. This isall one systemic function and/or aspect of this integrated device as asystem.

In various embodiments, a Vortex Flow Directing Implant (700), describedin connection with FIGS. 18 and 19, is substantially identical to thesystem (100) described hereinabove, with the substantial differencesnoted herein. For example, the member (710) is encased and circled (711)in an FIG. 21 inflatable ‘belt’ (711) intended to provide an adjustablesealing point or surface for the valvular leaflets (12) (13) to seatand/or seal (716) upon. The secured and/or fixated member (710) and isattached, fixated, and/or secured to the tether or shaft (200). Thisinflatable ‘belt’ (711) is integrated into the member (710) and may beinside (712) the lumen of the member (710) or outside (711) the lumenFIG. 22 of the member (710) positioned along the line of coaptation(716) or at the point the leaflets come into contact (716) with themember (710)(711). In this embodiment, the member (710) is the distalattachment to the force transducting or transferring fixed shaft (200)which is axially adjustable (206)(202)(308) as a complete assembly, maycontain FIG. 22 filling points; one upper fill point (713), one lowerfill point (714), one belt fill point (715). The tether or shaft (200)transitioning into an inner fixed shaft (204) and an outer axiallymoving shaft (202), the outer axially moving shaft (202) harboring anintegrated inflatable axially adjusting balloon (206), with the whole ofthe shaft transitioning (207) into a multi lumen tube (400) afterexiting the apex (5). The shaft (200), in its entirety, is fixed to theapex (5) of the heart by a base plate (300), either ball jointed (301)or not and either piston adjusted (307)(308) for axial adjustable heightor not initially mechanically secured onto the apex (5), and then, aftertransitioning (207) into a multi-lumen tube (400), to a control unit(500) that, may in some embodiments house or harbor intracardiacsensoring components, adjusts the device performance via a fluidcommunicating system when connected (506) to the multi lumen tube (400).This is all one systemic function and/or aspect of this integrateddevice as a system.

In various embodiments, a Vortex Flow Directing Implant (800), describedin connection with FIGS. 23 and 24, is substantially identical to thesystem (100) described hereinabove, with the substantial differencesnoted herein. For example, the member (810) is FIG. 26 semi-lunarshaped, malleable yet rigid, ‘manta’ shaped (120) and/or any othershape, being solid or rigidly malleable on the posterior half (811)(13)and inflatable (812)(12) on the anterior portion. (See FIG. 27) This maybe reversed as well, meaning the posterior half (13) is FIG. 28inflatable (812) and the anterior portion (12) is solid FIG. 29 (811).This creates the semi-lunar profile that the native mitral valvenaturally exhibits, meaning a semi-lunar line of coaptation (813), andmay sustain the atrioventricular pressure gradient in a more functionaland efficient manner. In this embodiment, the member (810) is the distalattachment (200) to the a multi lumen transducting fixed tether or shaft(200) which is axially adjustable (202)(206)(308) as a complete assembly(800)(100), the assembly transitioning into an inner fixed shaft (204)and an outer axially moving shaft (202), the outer axially moving shaft(202) harboring an integrated inflatable axially adjusting balloon(206), with the whole of the shaft transitioning (207) into a multilumen tube (400) after exiting the apex (5). The shaft (200), in itsentirety, is fixed to the apex (5) of the heart by a base plate (300),either ball jointed (301) or not and either piston adjusted (307)(308)for axial height or not, initially mechanically secured onto the apex(5), and then, after transitioning (207) into a multi lumen tube (400),to a control unit (500) that, may in some embodiments house or harborintracardiac sensoring components, adjusts the device performance via afluid communicating system when connected (506) to the multi lumen tube(400). This is all one systematic function and/or one aspect of thisintegrated device as a system.

In various embodiments, a Dual Force Pressure Mitigating Implant (600),described in connection with FIG. 30, is similar to the system (100)described hereinabove, with the substantial differences noted herein.The Dual Force Pressure Mitigating Implant (600) is a device within anintegrated system (200) (300) (400) (500) (100) (600) (700) (800) (900)with several composite components, sets of component, functions, parts,and/or aspects. The Dual Force Pressure Mitigating Implant (600)consists of two assembled component systems: the FIG. 34, 35 thepressure mitigating assembly (601) consisting of the structural housing(604), made up of components (603)(605)(606)(607)(617), eachself-expanding, made of nitinol, elastic, or spring-like material, thegradient funneling skirt (608), and the fixation point (611) is thefirst component system. The second component system is the ‘one wayvalve’ or ‘check valve’ (602). The ‘one way valve’ or ‘check valve’(602) is contained, mounted, and/or housed within the pressuremitigating assembly (601), consisting of the structural housing (604)and the gradient funneling skirt(608). .This finished component assembly(601), the pressure mitigating assembly (601), is then attached to thecomponents (200)(300)(400)(500); the tether or shaft (200), the apicalbase plate (300), which may in some embodiments be ball jointed (301)and/or hydraulically axially adjustable (307)(308), the multi-lumencommunication tubing (400), and the control unit (500) and togethercreate the embodiment.

The combination of these two-component assemblies (601)(602), thepressure mitigating assembly (601) and the ‘one way’ or ‘check valve’(602) become the FIGS. 30, 31, 32A Dual Force Pressure MitigatingImplant (600). The tether or shaft (200) in communication with thecontrol unit (500) via the multi-lumen tubing (400), may in someembodiments be used to axially adjust (206) (307) (308) the tension orseal on the atrial (2) side of the valve (7) at the point which thegradient funneling skirt (608) connected to the proximal annular ring(605) meets native or prosthetic valve (7) annulus (8). The axial heightof the shaft (200) also adjusts the amount of transductive force(meaning the mechanical capture, harness, collection, and transfer ofnative energy and force) delivered FIG. 33 by increasing or decreasingthe amount of load or pressure on and in the structural housing (604),made up of all of the nitinol, spring-like, self-expanding components(603)(605)(606)(607)(617), as it sits on the native atrial (2) annulus(8), mechanically delivered to ventricle (3), the septum (6), and/orventricular walls (4). By increasing or decreasing the load placed ontoor into the nitinol lateral (606), distal suspension ring (603),proximal annular ring (605), lateral struts (606), and crescent shapedstruts (607) making up the structural housing (604) the dual force oramplified force transduction is created. This combining or the joiningof these two components, the pressure mitigating assembly (601) and the‘one way valve’ or ‘check valve’ (602), the tether or shaft (200), theapical base plate (300), the multi-lumen communications tubing (400),and the control unit (500) now completes the integrated system referredto as the Dual Force Pressure Mitigating Implant (600).

The pressure mitigating assembly (601) is the structural housing (604)FIGS. 34, 35, consisting of a distal suspension ring (603) and aproximal annular ring (605) resting on or in the proximity of and/orbuttressing against the atrial (2) side annular ring (8) of the nativeor prosthetic valve (7). The distal suspension ring (603) and theproximal annular ring (605), connected by lateral struts or ribs (606),and bridged across the top by flexible cross section struts or crescentshaped struts (607) joining the lateral struts (606) after they connectto the distal suspension ring (603) complete the structural housing(604). This pressure mitigating assembly (601) functions in amulti-functional or multi-purpose role. The structural housing (604),within the pressure mitigating assembly (601), mounts and houses the‘one way valve’ or ‘check valve’ (602) which, in conjunction with thegradient funneling skirt (608), traps, contains, harnesses, seals, andthen re-directs the energy and force of the atrioventricular pressuregradient and the regurgitant volume (the representation of the gradientpressure loss). The pressure mitigating assembly (601) is the componentthat loads, stores, and releases that pressure gradient energy and forceenabling mechanical force transduction or transfer of re-purposed nativeenergy and force into the ventricle (3), the septum (6), and theventricular walls (4). The pressure mitigating assembly (601) beingfixed or secured at the fixation point (611), complete with the ‘one wayvalve’ or ‘check valve’ (602) mounted within, to the tether or shaft(200) and then to the apical base plate (300) connected by themulti-lumen tubing (400) to the control unit (500) completes theembodiment (600). Additionally, the pressure mitigating assembly's (601)structural housing (604) components (603)(605)(606)(607)(617) load andstore energy and force during the filling diastolic phase, as theventricle (3) elongates and stretches both in length and width (4) andthe nitinol or elastic propertied material the structural housing (604)is composed of is stretched, thus loading the spring with energy andforce. The structural housing (604) releases this diastolic loadedenergy and force during the ventricular ejection or the systolic phaseas the ventricle (3) compresses and contracts, thus releasing the springlike structural housing (604), the length and width rapidly contractingduring the process. When this contraction occurs, the structural housing(604), being that the nitinol or elastic propertied material isstretched or loaded (606)(607)(605)(603)(617) at this point, is releasedand the spring loaded (606)(607)(605)(603)(617) forces loaded are thusreleased. The distal suspension ring (603), proximal annular ring (605),the lateral struts (606), and the flexing cross sectional struts orcrescent shaped struts (607), made of nitinol or any other elastic,expandable, and/or rigidly flexing material, load energy and forceduring the filling phase, or diastole, as the ventricle (3) expands andlengthens, and then releases this energy and force during the ejectionphase, or systole, thus adding ventricular functional support in itsassist with the ejection of blood from the ventricle (3) and themechanical transducting or transferring of these forces via the tetheror shaft (200) to the apical base plate (300), and then via this baseplate (300) into the ventricle (3), the septum (6), and ventricularwalls (4).

The gradient funneling skirt (608) shown in FIGS. 34, 35 traps,captures, seals, steers, and funnels the regurgitant atrioventricularpressure gradient, demonstrated by the hemodynamic volume or regurgitantvolume present on the atrial side (2) of the heart valve (7) duringsystole, into the ‘one way valve’ or ‘check valve’ (602) at which pointit (the regurgitant volume) is contained and housed within the skirt(608) until such time that this volume is returned back into theventricle (3) during the filling or diastolic phase. The gradientfunneling skirt (608) traps, captures, seals, steers, and funnels theregurgitant volume, visualized by blood, on the atrial (2) side of thenative or prosthetic heart valve (7) and represents or demonstratesatrioventricular pressure gradient loss as visualized by regurgitantblood. The atrioventricular pressure gradient energies and forces becomea restoring, mechanically delivered, and re-purposed essentialrequirement for ventricular (3) health and the atrioventricular gradientpressure is critical to maintaining the health of the valve (7), theventricle (3), the septum (6), and the ventricular walls (4). Thegradient funneling skirt (608) is attached and/or fixed to the proximalannular ring (605) on the proximal end of the structural housing (604)and to the distal suspension ring (603) and ‘one way valve’ or ‘checkvalve’ (602) at the opposing or distal end above the ‘duck bill’ (612)at the distal suspension ring (603). The gradient funneling skirt (608)vectors this regurgitant volume loss into the ‘one way valve’ or ‘checkvalve’ (602) at which point the progress of the regurgitant volume isstopped or halted (612). The structural housing (604) lattice becomes/isthe housing, mount, or structural stability and anchor point for the‘one way valve’ or ‘check valve’ (602), as well as the fixation points(603) (605) for the gradient funneling skirt (608). The proximal annularring (605) holds the one way valve or check valve (602) in place on theannulus (8) securely on the atrial side (2) of the native or prostheticheart valve (7). The distal suspension ring (603) is the distal fixationpoint for the ‘one way valve’ or ‘check valve’ (602) with the distal endof the gradient funneling skirt (608) fixated or secured to the distalend of the ‘one way valve’ or ‘check valve’ (602). In its dual forcecapacity, the nitinol and/or elastic, expandable, spring like struts andcomponents of the structural housing (604)(603)(605)(606)(607)(617)still load in diastole and release in systole, thereby providingamplified and/or additional ventricular functional support to ejectionas well as force transduction benefits to the ventricle (3), the septum(6), and the ventricular walls (4).

The ‘one way valve’ or the ‘check valve’ (602) traps, stops, seals,halts, and/or impedes the atrioventricular pressure gradient loss as itescapes via the compromised or failing native or prosthetic heart valve(7) during ventricular (3) systole (the pumping or ejection phase). Thisloss is evidenced by blood volume flowing retrograde and visualized onthe atrial (2) side of the native or prosthetic heart valve (7) in theejection or systolic phase of the hearts cycle shown in FIGS. 35, 36,41, & 49. The ‘one way valve’ or ‘check valve’ (602) allows pressure,blood, and pressure gradient change (atrial high pressure versusventricular low pressure) to flow or pass through it (602) from theatrium (2), through said ‘one way valve’ or ‘check valve’ (602), andFIGS. 37, 38, 43, & 47 into the ventricle (3) but prevents theatrioventricular pressure gradient from leaking or regurgitating back(atrial low pressure versus ventricular high pressure) from ventricle(3) and returning back into the atrium (2) FIGS. 36, 40, & 41. It is the‘duck bill’ (612) feature of the ‘one way valve’ or ‘check valve’ (602)the open end or distal end (613) oriented toward the atrium (2) and theclosed or billed end (612) oriented proximally toward the ventricle (3).This orientation allows flow to pass through the ‘check valve’ (602)from the atrial/distal (2) (613) side and move through the ventricularoriented/proximal ‘duck bill’ (612) and into the ventricle (3) FIGS. 37,38, & 43. In FIG. 40, 41, blood flow and pressure attempting to returnfrom the ventricle (3) back into the atrium (2) is stopped and/orprevented by the closed ‘one way’ or ‘duck bill’ valve (612) andcontained and stopped or halted within the gradient funneling skirt(608) stopping and trapping (preventing the blood from returning to theatrium (2) from the ventricle (3) within the ‘skirt’ (608) because itsits and seals directly above the atrioventricular valve (7)) thisvolume at the closed, one way end, or ‘duck bill’ (612), of the ‘checkvalve’ (602). This positioning, above FIG. 33 the compromised native orprosthetic valve (7), as shown in FIG. 33, traps, stops, seals, and/orimpedes the loss of the atrioventricular pressure gradient within theventricle (3) and prevents regurgitant volume from moving into theatrium (2). The trapped, stopped, and/or impeded systolic regurgitantblood volume that is held proximal (612) to the ‘one way valve’ or‘check valve’ (602) and distal to the compromised native or prostheticvalve (7), returns into the ventricle during the FIG. 37, 38, 43diastolic phase, which occurs immediately after the systolic phase FIGS.36, 40, 41. As the ‘one way valve’ or ‘check valve’ (602)(612) ispositioned and fixed above and on the atrial (2) side of the heart valve(7), the valvular structures (12) (13) and subvalvular apparatus (11)are able to function freely and naturally without any interference fromthe ‘one way valve’ or ‘check valve’ (602) during the hearts cycle ofdiastole and systole. This repeats continuously throughout each completeheart's cycle.

The ‘one way valve’ or ‘check valve’ (602) is open and rounded FIG. 38at its distal or top end (613)(603), tapers and flexes FIG. 39 to aproximal end closed ‘duck bill’ (612) shaped FIG. 40), the distal end(603) being fixed and/or secured to the structural housing (604),distally by the distal suspension ring (603) and laterally by seamededges of the ‘duck bill’ (612) tapering up to the distal point of thedistal suspension ring (603) of the ‘check valve’ (602), and conforms(603) to the expansion shape of the nitinol, elastic, expandable, and/orrigid material. The structural housing (604) and the distal suspensionring (603) and the materials they are constructed of, be it nitinol,elastic, and/or expandable material. The ‘one way valve or ‘check valve’602, itself, is constructed of a ePTFE, Dacron, Teflon impregnatedDacron, polyurethane, silicone, polyurethane co-polymer, a laminate ofthe like and/or any other material, allows the ‘one way valve’ or ‘checkvalve’ (602) to conform to the topography of the atrial annulus (8), viathe FIG. 35 proximal suspension ring (605), it is positioned or seatedon the annulus (8) , in, and/or in proximity to and seals around theatrial side (2) of the annulus (8) and the compromised native orprosthetic valve (7) by way of the gradient funneling ‘skirt’ (608). The‘one way valve’ or ‘check valve’ (602) secured and fixed to thestructural housing (604) and housed inside of the pressure mitigatingassembly (601), as one of two component assemblies (602) (601). The twocomponent assemblies (601)(602) combine (200)(300)(400)(500) to becomethe integrated system distal attachment creating the embodiment calledthe Dual Force Pressure Mitigating Implant (600).

The structural housing (604), the gradient funneling skirt (608), andthe contained ‘one way valve’ or ‘check valve’ (602) are components ofthe pressure mitigating assembly. The pressure mitigating assembly (601)illustrated in FIGS. 34 & 35 is assembled of combined components(604)(608)(611), and is then combined with the ‘one way valve’ or ‘checkvalve’ (602), fixed in positioned above the atrioventricular valve (7)on the and on the atrial side (2) of the heart valve (7). The ‘one wayvalve’ or ‘check valve’ (602) is combined and housed in the pressuremitigating assembly (601), the pressure mitigating assembly (601) thenbeing fixed to the tether or shaft (200), the base plate (300), themulti-lumen tubing (400), and the control unit (500), which is fixed tothe apex (5) of the heart by the apical base plate (300), and connectedto and in communication with the control unit (500) via the multi-lumenconnective tubing (400). This combination becomes the therapeutic devicecalled or referred to as the Dual Force Pressure Mitigating Implant(600). The addition of the second assemblies or components(200)(300)(400)(500) stabilizes and holds in place the pressuremitigating assembly (601) above, in proximity to, and around the annulus(8) of the atrial (2) portion of the hearts valve (7) thus allowing thepressure mitigating assembly to trap, stop, seal, and/or to impede theatrioventricular pressure gradient loss as it escapes via thecompromised or failing heart valve during ventricular systole (thepumping or ejection phase). This is all a systematic function and/or oneaspect of this integrated device as a system.

The coapting vectoring member (615) may in some embodiments be presenton the Dual Force Pressure Mitigating Implant (600). It is a coaptingvectoring member (615), inflatable, solid, or semi-rigid, that allowsthe valvular leaflets (12) (13) and subvalvular apparatus & structures(11) to seal on (615) or ‘grab, flex, and pull’ on the coaptingvectoring member (615). The valvular leaflets (12) (13) and subvalvularapparatus (11) ‘grabbing, flexing, and pulling’ (10) (9) of the coaptingvector member (615) assists, enhances, and/or replaces lostvalvulo-ventricular interaction by transducting this native force viathe apical base plate (300) which then, by connection via the tether orshaft (200) to and contact with the apex (5), ventricle (3), andventricular wall (4). Additionally, the coapting vectoring member (615)allows for and facilitates ventricular (3) inflow and outflow vectorchange. This ability to change or alter inflow and outflow though thevalve (7) (12) (13) vector may enhance, facilitate, and/or restorevortex formation restoring vortical flow in the intracardiac space. Thisis all one systematic function and/or one aspect of this integrateddevice as a system.

Dual Force Pressure Coapting Implant—Another embodiment, described inconnection with FIG. 45-46, is substantially identical to the system(600) described hereinabove, with the substantial differences notedherein. The Dual Force Pressure Coapting Implant (619) is described asanother device within an integrated system. According to thisembodiment, the Dual Force Pressure Coapting Implant (619) consists of atherapeutic fixation assembly (614) and a ‘one way valve’ or ‘checkvalve’ (602). The therapeutic fixation assembly (614) being distallyattached or fixed (611) to the assembly known as the shaft or tether(200), connected or fixed to the base plate (300), and connected to thecontrol unit (500) via the multi-lumen tubing (400), which whencombined, are collectively known as the Dual Force Pressure CoaptingImplant (619). The therapeutic fixation assembly (614) has a structuralhousing (604) consisting of a proximal annular ring (605) intended torest on or near, be seated on or near, or be seated in or near the valveannulus (8), a distal suspension ring (603) framing the open distalfilling end (613) top (614) and serving as the distal fixation point forthe gradient funneling skirt (608) with the proximal end of the gradientfunneling skirt (608) fixated by the proximal annular ring (605), andstructural components such as the lateral struts (606) and the supportbeams (617) which structure the housing (614). An intravalvular ‘checkvalve, ‘one-way valve’, or ‘duck bill’ (602)(612) resting along a lineof coaptation (112), within the native valve (7), between the anterior(12) and posterior leaflets (13) as they seal or coapt in systole isfixed to the expanding proximal annular ring (605) which will splay outwithin the atrium (2) or atrially (2) above the native valve (7) aroundthe annulus (8). The gradient funneling skirt (608), fixed to the distalsuspension ring (603), acts as a flow funneling or flow directingsealing barrier allowing blood to freely flow from the atrium (2)through the one way valve or ‘duck bill’ (602) and into the ventricle(3), while remaining and being fixed (611) or attached to thetherapeutic fixation assembly (614), during diastole or the fillingphase of the cardiac cycle.

The expanding distal suspension ring (603) will be in connection withthe proximal annular ring (605) via fixation to or with the lateralstruts (606) and the gradient funneling skirt (608). The gradientfunneling skirt (608), located on the inflow side, between the distalsuspension ring (603) and the proximal annular ring (605) in thisembodiment, directs and vectors flow, FIGS. 47, 48, 49 from the atrium(2) into the ventricle (3), into and through the intravalvular ‘one-wayvalve or ‘duck bill’ (602). The intravalvular ‘one-way valve’ or ‘checkvalve’ (602) or ‘duck bill’ (612) valve housing is attached or fixedonto the proximal annular ring (605) and then its proximal end protrudesin between the anterior (12) and posterior (13) valve leaflets (12)(13)within the valve (7) structure itself where it remains fixed. By beingin close proximity to the intravalvular check valve’ or one way valve(602) fixated to the proximal annular ring (605), blood is allowed toflow from the inflow atrial (2) side to the outflow ventricular (3) sidebut not in the FIG. 49 reverse meaning ventricular (3) to atrial (2).The intravalvular ‘check valve’ (602) or intravalvular ‘one way valve’(602) has leaflets or appendages (narrowing into ‘duck bill shape’ (612)creating a backflow resistant proximal end (612)); features that aredesigned and/or intended to steer, guide, direct and or vectorhemodynamic flow during diastole and to seal off the ventricle (3) fromthe atrium (2) during ventricular systole. The device is held inposition with lateral struts (606) connected to support beams (617) orconnecting struts that connect or are fixed to the proximal annular ring(605) and then to the therapeutic fixation assembly (614) at thefixation point (611) at the end of the tether or shaft (200). Thetherapeutic fixation assembly (614) is part of the integrated systemthat includes the tether or shaft (200), the apical base plate assembly(300), and the control unit (500). This is all one systematic functionand/or one aspect of this integrated device as a system.

The therapeutic fixation assembly (614) (as shown in FIGS. 51, 53-55)consists of two components: the structural housing (604), combining thestructural components (603)(605)(606)(617) and the gradient funnelingskirt (608). The ‘one-way valve’ or ‘check valve’ (602) with a ‘duckbill’ (612) is then mounted or housed in the therapeutic fixationassembly (614). The structural housing (604) frame includes the distalsuspension ring (603), the lateral struts (606), support beams (617) andthe proximal annular ring (605). The one-way valve or ‘check valve’valve (602) is connected to the proximal annular ring (605) andfunctions to permit or allow flow in one direction by the ‘duck bill’backflow resistant end (612). The gradient funneling skirt (608) is thecomponent fixated between the distal suspension ring (603) and theproximal annular ring (605). The gradient funneling skirt (608)functions as a flow funneling and regurgitant-sealing component for thevectoring one-way valve or ‘duck bill’ (602). The gradient funnelingskirt (608) is held in proximity to the atrial endocardium by the distalsuspension ring (603) and/or the proximal annular ring (605). Thesupport beams (617) extend from the central tether or shaft (200) to thelateral struts (606) which are both fixated to the proximal annular ring(605). The distal suspension ring (603) is fixated to the lateral struts(606) and the lateral struts (606) are fixated to the proximal annularring (605). The support beams (617) and the lateral struts (606), beingattached or fixated to the distal suspension ring (603) and the proximalannular ring (605), provide form and shape as the structure self-expandsand/or contracts and FIG. 52 enables (610) force transduction, meaningthe capture, harnessing, redirection, and release, of the energy andforce of the systolic pressure gradient as the native valve's leaflets(12)(13) act to ‘grab, flex, and pull or act on the surface area of the‘one way valve’ or ‘check valve’ (602). The energy and force is thendelivered via the structural housing (604) to the shaft (200) to thebase plate (300) and into the impaired ventricular structures(4)(5)(6)(9)(10) and within the ventricle (3) captured as the one wayvalve or ‘duck bill’ (602) is seals in systole. The energy and force ofthe atrioventricular pressure gradient within the ventricle (3), thenative force that closes the valve (7) leaflets around the tether orshaft (200) and seals closed the ‘one-way valve’ or ‘check valve’ (602)is then mechanically delivered via the therapeutic fixation assembly(614) and the ‘one way valve’ or ‘check valve’ (602) into the ventricle(3), the septum (6), and the ventricular walls (4).

The Dual Force Pressure Coapting Implant (619), is describedhereinabove. This assembly consists of the therapeutic fixation assembly(614) containing the one-way valve or check valve (602),a tether orshaft (200), a base plate assembly (300), which may be ball jointed(301) or piston adjusting (308), a multi-lumen connective tubing (400),and a control unit (500) in communication with the distal deviceattached to the tether or shaft (200).

The Dual Force Annular Implant, (900), another embodiment of the deviceas shown in FIG. 44, is substantially identical to the system(600)(619)(100) described hereinabove, with the substantial differencesnoted herein. The dual force annular halo (901), is made of Nitinol, orelastic spring-like, memory based material and is self-expanding aroundthe annulus (8) on the atrial (2) side of the atrioventricular valve(7). The dual force annular halo (901) is fixed to the shaft (200) ortether, which is fixed to the base plate (300), which is connected viamulti-lumen tubing (400) to the control unit (500). By fixing the dualforce annular halo (901) on the atrial (2) side of the atrioventricularvalve (7), the valve plane (8)(7) is mechanically connected to the apex(5) of the heart (1) and thus, the shaft making the connection, becomes,in effect, an additional or third papillary muscle (9)(10)(11)delivering targeted maximum energy and force of the atrioventricularpressure gradient via mechanical force transduction (meaning thecapture, harnessing, collection, and transfer of existing native energyand force) into the ventricular structures (4)(5)(6), the ventricle (3),the apex (5), and the septal wall (6). The dual force annular halo (901)loads energy and force in diastole, as the ventricle (3) stretches,fills, and prepares for contraction, and releases during the systoliccycle dramatically assisting in ventricular ejection. The dual forcemechanics, spring loading energy and force in one cycle and releasing itin an contractile release in another, as is seen in the Dual ForceAnnular Implant (900) is mechanically replicated within the Dual ForcePressure Mitigating Implant (600) and the Dual Force Pressure CoaptingImplant (619) (as shown in FIGS. 30, 31, 45 & 46) in two forms or ways.First, the mechanical connection between the valvular plane (8)(7) andthe apex (5) via a distal attachment (600)(601)(619)(614)(200)(300) fromthe valve plane to the apex is mechanically created. The pressuremitigating assembly (601), as part of the Dual Force Pressure MitigatingImplant (600), assists the ventricle (3) by connecting the valve plane(7)(8) with the apex (5) via the shaft (200) thus functioning as anartificial or mechanical papillary muscle (9)(10)(11) and captures theatrioventricular pressure gradient energy and force, whilesimultaneously mitigating the atrioventricular pressure gradient loss,and then loading this energy and force into the nitinol or spring-likestructural housing (604)(603)(605)(606)(617) during one phase (diastole)and subsequently releasing this force in the next phase (systole), acontractile release, in the next phase acting as an added ventricularassist. This function thereby utilizes the native pressure differentialbetween the ventricle (3) and the atrium (2) found naturally within theventricle during the hearts cycle as a therapeutic modality. Theconnection of the valvular plane (8)(7) to the apex (5), assisting theventricle (3) is accomplished via the device (619)(600) via a proximalannular ring (605) joined or resting on or in proximity to the heartvalve annulus (8), either prosthetic or native, which is connected (611)or linked to the shaft or tether (200) by lateral struts (606) orsupport beams (617) and the tether/shaft (200) which is held in place bythe base plate (300). Secondly, the tether and or shaft (200) fixated(611) in combination with the lateral struts (606) and the support beams(617) deliver to and are the connection and communication between theproximal annular ring (605) and the base plate (300) and they functionto reconnect and link the valvular plane (8)(7) to the apex (5) to theventricle (3) to capture, harness, restore, and transduct or transferthe native forces of physiologic intracardiac flow and the cardiaccycle, the atrioventricular pressure gradient to the structures of theventricle (3)(4)(5)(6) that the chordae tendineae (9) and papillarymuscles (10) normally deliver in a healthy unaffected human heart. Thismechanical connection restores this capacity of the injured heart,which, due to the insult or pathology, can no longer deliver or deliversit in a reduced or diminished capacity, and/or delivers a dysfunctionaland ineffective valvulo-ventricular interaction with the ventricularstructures (4)(5)(6) and ventricular walls (4). An additional functionis transducting, or transferring and delivering the atrioventricularpressure gradient energy and force captured (610) by the ‘one way valve’or ‘check valve’ (602) with the gradient funneling skirt (608) via thecoapting intravalvular surface (610) along the line of coaptation (112)of the therapeutic fixation assembly (614) atrial fixation of thepressure mitigating assembly (601). The pressure gradient is capturedacross the area of the one-way valve’ or ‘check valve’ (602) andgradient funneling skirt (608) and the resulting force is thentransducted into the structural housing (604) and through thetether/shaft (200) to the base plate (300) on the apex (5). This actionmechanically transducts or transfers the energy and force that anincompetent valve (7), meaning a valve (7) losing the atrioventricularpressure gradient, to the structures the impaired ventricle (3) andheart (1) would not be able to support and maintain without assistance.Through the mechanical connection from the valvular plane (8) (7) toapex (5) and thereby the ventricle (3), the connection coupled with theenergy and force captured by the ‘one way valve’ or ‘check valve’ (602)and pressure mitigating assembly (601) or the therapeutic fixationassembly (614) the embodiments (600)(619) (900) functions torehabilitate the ventricle (3) and its structures (4)(5)(6)(11) and, byproxy, the heart (1).

Each of the above described embodiments reflects an integrated systemincluding a distal member or attachment (110)(710)(810)(601)(614)(901)having a universal tether or shaft (200), a universal base plate (300),the universal connective tubing (400), and the universal control unit(500). The interchangeable ‘members’ (110)(710)(810)(901) (as shown inFIGS. 10, 21, & 26), the Dual Force Annular Band (900)(901) (as shown inFIG. 44), the pressure mitigating assembly (601) (as shown in FIGS. 34 &35), the therapeutic fixation assembly (614) (as shown in FIGS. 51, 53,54, 55), the Dual Force Pressure Mitigating Implant (600) (as shown inFIGS. 30 & 31), and the Dual Force Pressure Coapting Implant (619) (asshown in FIGS. 45 & 46) in all embodiments, are interchangeable distalassemblies with the universal components (200)(300)(400)(500). Thoseuniversal components include the universal tether or shaft (200), theuniversal base plate (300), the universal connective tubing (400), andthe universal control unit (500). All of these components(110)(710)(810)(601)(901) combine in combination with a distal tether orshaft component (200) as one integrated system to treat vortical flowFIG.1 (110)(710)(810)(619), shape (110)(710)(810)(601)(614)(901), andpressure (110)(710)(810)(601)(614) dysfunction in either ventricle (4)of the human heart as a primary therapy or as an adjunct therapy with orwithout either native or prosthetic atrioventricular valves (7) and/orother prosthetic devices. All of the components, parts, and sub-systemsmentioned are a part of this device as an integrated system.

In various embodiments, an integrated implant system may be surgicallyimplanted via transcatheter delivery in the human heart (1)(2)(3) in atransapical manner, via a left side thoracotomy (1218) with atransapical access (5). In various embodiments, the implant system maybe implanted in a minimally invasive procedure as described in moredetail below. With the apical base plate assembly (300) replaced by theuniversal splayhook anchor plate (1101), each of the above describedembodiments (100)(600)(619)(700)(800)(900) may also be implanted in atrue transcatheter manner. This transcatheter method of implant is lessinvasive and more easily tolerated by patients. The apical base plateassembly (300)(301)(302) is replaced with a universal splayhook anchorplate (1101) that is delivered via a procedural steerable sheath (1200).The universal splayhook anchor plate (1101) is pre-assembled andpre-connected into the proximal end (1105) of the integrated systemsshaft (200)(1105) at the central universal ball mount (1103) with themale universal ball connector (1113) coupled inside the shaft(200)(1105).

FIGS. 58A and 58B illustrate an intracardiac device (100A) coupled to asplayhook anchor plate (1101). As shown in FIGS. 58A and 58B, the shaft(200) transitions into a universal receiver (1104)(1105), located at theproximal end of shaft (200), couples to, is fixed to, and is rotational360 degrees on and while coupled to the male universal ball connector(1113) on the central universal ball mount (1103), located at the centerof the universal splayhook anchor plate (1101). The universal shaftreceiver (1104), located at the proximal end of the shaft (200)(1105),connects each of the above described embodiments(100)(600)(619)(700)(800)(900) to the central universal ball mount(1103) and, thus, to the universal splayhook anchor plate (1101). Theuniversal splayhook anchor plate (1101) functions the same way theapical base plate assembly (300) does in that it fixes and holds inplace (1104) the shaft (200)(1105) which is fixed to the distal member(110)(601)(614)(710)(810)(910) because the universal splayhook anchorplate (1101) is anchored, fixed, and secured to the medial (1106) andlateral (1107) papillary muscles (10) inside the ventricular chamber. Invarious embodiments, the design of the universal splayhook anchor plate(1101) and the components used in the assembly are such that it (1101)is mechanically more efficient than the apical base plate assembly (300)because it delivers all of the forces of the atrioventricular pressuregradient and the energy and force associated with it, as describedabove, directly into the papillary muscles, at their base thereby moremechanically, efficiently, and accurately restores and imparts lostnatural and native function and purpose. The universal splayhook anchorplate (1101) is assembled from the following components; the centraluniversal ball mount (1103), the male universal ball connector (1113)that the universal shaft receiver (1104) couples and fixates onto(1113), and the four splayhook fixation wires (1108), a right uppersplay hook fixation wire (1110) & left upper splayhook fixation wire(1109) and a right lower splayhook fixation wire (1112) & left lowersplayhook fixation wire (1111). On the distal end of each splayhookfixation wire (1108) is a barbed splayhook tissue anchor (1102) whichanchors or fixates each individual splayhook fixation wire (1108), thebarbed splayhook tissue anchor (1102) being the distal component of thiswire and being fixated to the wire (1108), securely into the papillarymuscles (10), both medial (1106) and lateral (1107), seated or securedinto the tissue by the tension and pull between the opposing medial(1106) and lateral (1107) papillary muscles (10). The splayhook fixationwires (1108) extend in a reverse taper from the central universal ballmount (1103) with the right upper splayhook fixation wire (1110)crossing above (1114) the right lower splayhook fixation wire (1112) andthe left lower splayhook fixation wire (1111) crossing above (1115) theleft upper splayhook fixation wire (1109) thereby creating a rightpressure opening crossing point (1114) and a left pressure openingcrossing point (1115). The distal ends, at the pressure opening crossingpoints (1114) (1115) , of the splayhook fixation wires (1108) now openunder direct pressure at the right (1114) and left (1115) pressureopening crossing points (1114) (1115) and will close from memory, at thesame points (1114)(1115), immediately after the papillary muscles (10)pass through the this open channel. The open channel is created at andin the right pressure opening crossing point (1114) by the right upperand lower splayhooks fixation wires (1110)(1112) being pressed directlyinto and against the medial papillary muscle (1106) by steering theprocedural sheath distal end (1201) toward the medial papillary muscle(1106). This opens the channel by pressing the right pressure openingpoint (1114) directly against the medial papillary muscle (1106) causingthe right upper and lower splayhook fixation wires (1110) (1112) to movein opposite directions creating an opening or a channel through whichthe medial papillary muscle (1106) passes until the memory causes rightupper and lower splayhook fixation wires (1110) (1112) to close, as nostructure is holding them open because the medial papillary muscle(1106) has passed through the channel. This procedure is now repeated,on the lateral papillary muscle (1107) with the left pressure openingcrossing point (1115). The open channel is created at and in the leftpressure opening crossing point (1115) by the left upper and lowersplayhooks fixation wires (1109)(1111) being pressed directly into andagainst the lateral papillary muscle (1107) by steering the proceduralsheath distal end (1201) toward the medial papillary muscle (1107). Thisopens the channel by pressing the left pressure opening point (1115)directly against the lateral papillary muscle (1107) causing the leftupper and lower splayhook fixation wires (1109) (1111) to move inopposite directions creating an opening or a channel through which thelateral papillary muscle (1107) passes until the memory causes leftupper and lower splayhook fixation wires (1109) (1111) to close, as nostructure is holding them open because the lateral papillary muscle(1107) has passed through the channel.

FIG. 59 illustrates an intracardiac device (100A) placed within a heartchamber. Tension is created between the connection (1102) at either end(1107)(1106) of the universal splayhook anchor plate (1101), the lateralpapillary muscle (1107) on one end and the medial papillary muscle(1106) on the other end, which cause the barbed splayhook tissue anchorpoints (1102) to press in (10), anchor (10), and seat (10) into therespective papillary muscles (1107)(1106). The anterior and posteriorvalve leaflets ‘grabbing, flexing, and pulling’ on the member duringsystole and releasing during diastole will, additionally, cause thesplayhooked barbed anchor points (1102) to press in (10), anchor into(10), and seat properly (10) into the respective papillary muscles(1107)(1106). The member (110), in any shape or embodiment, interceptsatrial (2) blood and re-vectors (111) it to assist, enhance, or restorethe vortex, vortical flow, and natural physiologic blood flow vectorpassing blood over, across, and off of the valve leaflets and into theventricle (3) and it captures (112) the native atrioventricular pressuregradient, or the ventricular energy and force, utilizing the valvular(12)(13) and subvalvular structures (11) as they coapt or seal(12)(13)(112) and thus ‘grab, flex, and pull’ (112) on the member (110)in systole. The ‘grabbing, flexing, and pulling’ (more preciselydescribed as atrioventricular pressure gradient forces acting on exposedarea of the member (110) at the line of coaptation (112)) by thevalvular (7)(12)(13) and subvalvular structures (9)(10)(11),mechanically replaces and imparts the disturbed or lost native valvularand subvalvular force (driven by the systolic atrioventricular pressuregradient) interaction with the ventricle (3), the ventricular structures(4)(5)(7), the septal wall (6), and ventricular walls (4) bytransducting, meaning the capture, collection, and transfer of existingnative energy & force, this native force via the universal splayhookanchor plate (1101), fixed to and in physical contact with medial (1106)and lateral (1107) papillary muscles (10), and therefor with the, theventricle (3), ventricular structures (4)(5)(6)(7), and ventricular wall(4). This is one systemic function and/or aspect of this transcatheterdevice within an integrated system.

In various embodiments, the splayhook anchor plate (1101) may be coupledto any of the intracardiac devices described herein to thereby anchorand/or position the intracardiac device within a heart chamber. Thesplayhook anchor plate (1101) may be suitable for minimally invasivedelivery of any of the intracardiac devices described herein via acatheter as is known in the art. For example, FIGS. 60A and 60Billustrate an intracardiac device (600A) coupled to a splayhook anchorplate (1101). The splayhook anchor plates (1101) illustrated in FIGS.60A and 60B are substantially similar to those illustrated in FIGS. 57Aand 57B.

FIG. 61 illustrates an intracardiac device (600A) having a splayhookanchor plate (1101) attached to the lateral (1107) and medial (1106)papillary muscles. The splayhook anchor plate (1101) shown in FIG. 61 isattached to the heart chamber via the papillary muscles in asubstantially similar manner to that shown in FIG. 59.

In another example, FIGS. 62A and 62B illustrate an intracardiac device(619A) coupled to a splayhook anchor plate (1101). The splayhook anchorplates (1101) illustrated in FIGS. 62A and 62B are substantially similarto those illustrated in FIGS. 57A and 57B.

FIG. 63 illustrates an intracardiac device (619A) having a splayhookanchor plate (1101) attached to the lateral (1107) and medial (1106)papillary muscles. The splayhook anchor plate (1101) shown in FIG. 63 isattached to the heart chamber via the papillary muscles in asubstantially similar manner to that shown in FIGS. 59 and 61.

A transcatheter procedure utilizing standard transcatheter accessapproaches, those being defined as the transfemoral (1216), transvenous(1215), and subclavian or transjugular (1217) approaches, and standardmedical transcatheter techniques, may be used to implant all of theembodiments (100)(600)(619)(700)(800)(900) of the transfemoralintegrated system. The access site to the blood vessel may be throughany clinically relevant location with the primary locations being apercutaneous femoral vein access (1215), a subclavian access (1217), ora jugular access (1217). An introducer sheath is then inserted into theselected vessel. Through the sheath, a guidewire, dilator, and steerableor preformed sheath is used to guide the distal end of both theguidewire and the sheath to the FIG. 3 fossa ovalis (1203). The sheath,dilator and guidewire can be maneuvered easily to the fossa ovalis(1203) under fluoroscopy or echocardiography imaging. The fossa ovalis(1203) is a naturally occurring depression in the right atrium (2) inthe interatrial septal wall (1204) and is a common, well known, standardanatomical landmark to medical professionals. By FIG. 3 puncturing thethin membrane covering over the fossa ovalis (1203), the left atrium (2)can be accessed from the right atrium (2). Various techniques exist forpuncturing the membrane including a needle, a Brockenbrough needle, aradio frequency catheter, and or a sharpened guidewire are commonlyused. Once the septum (1204) is punctured the site can be dilated up, orenlarged, to accommodate the implant or device delivery sheath size andto place the steerable procedural sheath (1200) inside the left atrium(2). The transeptal (1203) puncture allows access to the left atrium (2)and the steerable procedural sheath (1200) is then guided, antegrade(meaning in the direction of blood flow), through the mitral (7) oratrioventricular valve (7) and into the left ventricle (3). In the leftventricle (3) the FIG. 4 medial (1106) and lateral (1107) papillarymuscles (10) are visualized. The steerable procedural sheath (1200) isdirected or maneuvered in between the lateral (1107) and medial (1106)papillary muscles (10) and the advance is then stopped. A universalsplayhook anchor plate (1101) is fully extended from the distal end ofthe introducing steerable sheath (1201), that retraction and extensionstopping at the central universal ball mount (1103), the point at whichthe universal shaft receiver (1104) is coupled (1103)(1113)(1104)(1105)to the shaft (200). The shaft (200) and member (110) or distalintegrated system attachment (601)(614)(710)(810)(910) still remainshoused within the steerable procedural delivery sheath (1200) and isconnected and coupled (1103)(1113)(1104) to the universal splayhookanchor plate (1101). FIG. 57 The universal splayhook anchor plate (1101)is exposed and the medial papillary muscle (1106) is captured bysteering the procedural steerable sheath (1200) to the medial papillarymuscle (1106) and applying direct pressure on the right pressure openingcrossing point (1114). The right pressure opening crossing point (1114)opens, under direct pressure, and a channel is created as the rightupper and lower splayhook fixation wires (1110) (1112) move in oppositedirections allowing the medial papillary muscle (1106) to pass throughthe channel and then the memory closes the right pressure openingcrossing point (1114). The procedure is now repeated on the lateralpapillary muscle (1107). The lateral papillary muscle (1107) is capturedby steering the procedural steerable sheath (1200) to the lateralpapillary muscle (1107) and applying direct pressure on the leftpressure opening crossing point (1115). The left pressure openingcrossing point (1115) opens, under direct pressure, and a channel iscreated as the left upper and lower splayhook fixation wires (1109)(1111) move in opposite directions allowing the lateral papillary muscle(1107) to pass through the channel and then the memory closes the leftpressure opening crossing point (1115). The barbed splayhook tissueanchors (1102) on the distal ends of the splayhook fixation wires(1110)(1112)(1109)(1111), which splay and open (1115)(1114) under directpressure, thus allowing the papillary muscles (10)(1106)(1107) to passthough the splayed or opened channel. The barbed splayhook tissue anchorpoints (1102) press into (10), anchor into (10), and seat properly (10)into the respective papillary muscles (10)(1107)(1106) thus securing theuniversal splayhook anchor plate (1101). The procedural steerable sheath(1200) is then retracted from the central universal ball mount (1103),where it had been halted to capture and anchor the papillary muscles(1106)(1107), leaving universal splayhook anchor plate (1101), from theuniversal ball mount (1103), and the shaft (200) with the integratedsystem distal attachment or member (100)(600)(619)(700)(800)(900)deployed or released from the introducing sheath (1200) as it isretracted. The integrated system distal attachment(100)(600)(619)(700)(800)(900) or member (100)(600)(619)(700)(800)(900)is deployed or released in position, either within the atrioventricularvalve orifice (7)(16) or on the atrial (2) annulus (8), depending uponthe embodiment being implanted. The multi-lumen tubing (400) is leadfrom the atrial (2) side of the implant through the fossa ovalis (1203)and to the sub-clavian (1217) or jugular (1217) access site. Near theaccess site a small incision is made at an appropriate site for thesubcutaneous control unit (500) to be placed. A pocket is formed in thetissue and the multi-lumen tubing is tunneled to the site for thesubcutaneous control unit (500). The tubing (400) is then connected tothe control unit (500). The system may be fluidically connected and canhave a final flush via the control unit access sites. Final adjustmentscan then be made to the implanted system (100)(600)(619)(700)800(900)via the axially adjustable shaft (200)(202)(206). Typically, anon-coring needle is used to puncture into the control unit (500) toadjust or dial in the level of force transduction therapy or final fillvolume of the device.

The flowchart and block diagrams in the figures illustrate thearchitecture, functionality, and operation of possible implementationsof systems, methods, and computer program products according to variousembodiments of the present disclosure. In this regard, each block in theflowchart or block diagrams may represent a module, segment, or portionof instructions, which comprises one or more executable instructions forimplementing the specified logical function(s). In various alternativeimplementations, the functions noted in the block may occur out of theorder noted in the figures. For example, two blocks shown in successionmay, in fact, be executed substantially concurrently, or the blocks maysometimes be executed in the reverse order, depending upon thefunctionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts or carry out combinations of special purpose hardwareand computer instructions.

The descriptions of the various embodiments of the present disclosurehave been presented for purposes of illustration, but are not intendedto be exhaustive or limited to the embodiments disclosed. Manymodifications and variations will be apparent to those of ordinary skillin the art without departing from the scope and spirit of the describedembodiments. The terminology used herein was chosen to best explain theprinciples of the embodiments, the practical application or technicalimprovement over technologies found in the marketplace, or to enableothers of ordinary skill in the art to understand the embodimentsdisclosed herein.

What is claimed is:
 1. An implant system for restoring and changingphysiological intracardiac flow, mitigating atrioventricular pressuregradient loss and valvular regurgitation, and utilizing the nativepressure gradient as a reconstructive therapeutic force in a human heartcomprising: a dual-force pressure mitigating implant comprising: a ‘oneway valve’ or ‘check valve’ mounted within a ring structure that allowsatrial blood to pass through it into the ventricle but preventsventricular blood from returning into the atrium; and a pressuremitigating assembly having a mechanical dual force structural housinghaving a proximal annular expanding ring structure, a distal suspensionring, and ‘gradient funneling skirt’, the proximal annular expandingring structure supporting the valve skirt that seals to the distalsuspension ring, the distal suspension ring supporting the ‘one way’ or‘check valve’; an anchoring system comprising one or more therapeuticbase plate assemblies attachable to the heart's apex or wall orstructures; a universal tether assembly, comprising a tether or tethersor shaft, connected between the pressure mitigating assembly and theanchoring system, wherein the pressure mitigating assembly remainingtethered to the apex of the heart via the shaft and via the apical baseplate; a conduit providing a fluidic connection; and a control unit withmultiple sealed chambers to control the volume in the fluidic lumens andbladders and to house sensor components.